Biofilm protection implant shield

ABSTRACT

Apparatus, systems, and methods for inserting prosthesis implants into surgically-created implant pockets in a subject and for preventing capsular contracture resulting from surgical insertion of prosthesis implants. The apparatus includes a base having an upper surface and a lower surface and having an aperture formed therein which extends through the upper surface and the lower surface of the base. The apparatus also includes a tubular member that is coupled to the base. The inner bore of the tubular member is operable to receive the implant and has a substantially uniform cross-sectional width over the predetermined length. The apparatus is capable of shielding the implant from microbial contamination, including contamination by the endogenous flora of the subject, during insertion of the implant into the surgically-created implant pocket.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.16/709,785, entitled “Biofilm Protection Implant Shield,” filed Dec. 10,2019, which claims the benefit of U.S. Provisional Application Ser. No.62/847,151, entitled “Biofilm Protection Implant Shield,” filed May 13,2019, the contents of each of which are incorporated by referenceherein, for all purposes, in their entirety.

FIELD OF TECHNOLOGY

The present disclosure is directed to the insertion of prosthesisimplants into a surgically-created implant pocket of a subject. In somespecific instances, the present disclosure is directed to the insertionof breast implants, including un-filled implants and pre-filled implantssuch as silicone breast implants and pre-filled saline implants. Thepresent disclosure is further directed to methods, devices, and systemsfor inserting prosthesis implants in the surgically-created implantpocket of a subject as well as methods for preventing capsularcontracture resulting from surgical insertion of prosthesis implants.

BACKGROUND

Capsular contracture remains the most common complication of aestheticbreast augmentation despite advances in the understanding of thebiological processes which appear to be involved. Capsular contractureis characterized by the tightening and hardening of the capsulesurrounding the implant. The role of biofilms in capsular contracturehas been reported extensively and is believed to play an important rolein the pathogenesis of capsular contracture. Recent advances inantibiotic irrigation as well as the use of skin barriers and nippleshields has assisted in the reduction of capsular contracture. Yet,despite these advances, a significant number of women develop capsularcontracture following breast augmentation and require revisional surgeryor live with discomfort, deformity, or suboptimal results.

Form-stable implant studies with textured devices have shown lowercapsular contracture rates compared to smooth round devices. However,anaplastic large cell lymphoma (ALCL) is an indolent lymphoma found inwomen with textured implants. Biofilm infection is hypothesized to beinvolved in the development of both capsular contracture and ALCL. It issuspected that a source of the biofilm infection may be microbes fromthe skin and/or exposed breast tissue of the patient that come incontact with the sterile implant during insertion into thesurgically-created implant pocket. In particular, the subject'sendogenous flora present at the time of the surgery, including thosebacteria that may be present in the dissection tunnel connecting theskin incision to the surgically-created implant pocket or the skinsurface itself, may attach to the surface of the implant duringplacement in the implant pocket. Following insertion of the implant, thebacteria may colonize the surface of the implant and form a biofilm. Ifthe surface of the implant is colonized by a large number of bacteria,the subject's defenses may be overwhelmed and the biofilm may trigger achronic inflammatory response leading to subsequent fibrosis andaccelerated capsular contracture. Accordingly, methods and devicescapable of shielding the implant from microbial contamination, includingcontamination by the endogenous flora of the subject, during insertionof the implant into the surgically-created implant pocket are desirable.

BRIEF DESCRIPTION OF THE DRAWINGS

In order to describe the manner in which the advantages and features ofthe disclosure can be obtained, reference is made to embodiments thereofwhich are illustrated in the appended drawings. One of skill in the artwill understand that the reference numbers in the following figures arerepeated throughout FIGS. 1-32 so as to refer to the same orsubstantially the same features. Understanding that these drawingsdepict only exemplary embodiments of the disclosure and are nottherefore to be considered to be limiting of its scope, the principlesherein are described and explained with additional specificity anddetail through the use of the accompanying drawings in which:

FIG. 1 is an isometric view of the implant shield apparatus, accordingto an exemplary embodiment of the present disclosure;

FIG. 2 is a planar view of the implant shield apparatus, according to anexemplary embodiment of the present disclosure;

FIG. 3 is a front diagrammatic view of the implant shield apparatusshowing the distal end of tubular member and the lower surface of thebase, according to an exemplary embodiment of the present disclosure;

FIG. 4 is a rear diagrammatic view of the implant shield apparatusshowing the proximal end of the tubular member and the upper surface ofthe base, according to an exemplary embodiment of the presentdisclosure;

FIG. 5 is an isometric view of an implant shield apparatus having asubstantially circular base, according to an exemplary embodiment of thepresent disclosure;

FIG. 6A is a rear diagrammatic view of an implant shield apparatus in anunrolled configuration in which an end of the tubular member may berolled on itself to form a base, according to an exemplary embodiment ofthe present disclosure;

FIG. 6B is an isometric view of an implant shield apparatus in therolled configuration in which an end of the tubular member is rolled onitself to form a base, according to an exemplary embodiment of thepresent disclosure;

FIG. 7A is a rear diagrammatic view of an implant shield apparatus inthe undeployed configuration in which an end of the tubular member isperforated so as to be deployable to form a base, according to anexemplary embodiment of the present disclosure;

FIG. 7B is a rear end diagrammatic view of an implant shield apparatusin the deployed configuration in which an end of the tubular member isdeployed so as to form a base having a plurality of substantiallyrectangular flanges, according to an exemplary embodiment of the presentdisclosure;

FIG. 7C is an isometric view of an implant shield apparatus in thedeployed configuration in which an end of the tubular member is deployedso as to form a base having a plurality of substantially rectangularflanges, according to an exemplary embodiment of the present disclosure;

FIG. 8A is a rear diagrammatic view of an implant shield apparatus inthe undeployed configuration in which an end of the tubular member isperforated so as to be deployable to form a base, according to anexemplary embodiment of the present disclosure;

FIG. 8B is a rear end diagrammatic view of an implant shield apparatusin the deployed configuration in which an end of the tubular member isdeployed so as to form a base having a plurality of substantiallytrapezoidal flanges, according to an exemplary embodiment of the presentdisclosure;

FIG. 8C is an isometric view of an implant shield apparatus in thedeployed configuration in which an end of the tubular member is deployedso as to form a base having a plurality of substantially trapezoidalflanges, according to an exemplary embodiment of the present disclosure;

FIG. 9 is an illustration depicting the creation of a periareolarincision in the breast of a subject; according to an exemplaryembodiment of the present disclosure;

FIG. 10 is an illustration depicting the opening of the periareolarincision using two retractors, according to an exemplary embodiment ofthe present disclosure;

FIG. 11 is an illustration depicting insertion of the distal end of thetubular member of the implant shield into the dissection tunnelconnecting the periareolar incision to the surgically-created implantpocket, according to an exemplary embodiment of the present disclosure;

FIG. 12 is an illustration depicting further insertion of the tubularmember into the dissection tunnel, according to an exemplary embodimentof the present disclosure;

FIG. 13 is an illustration depicting engagement of the lower surface ofthe base of the implant shield with at least a portion of the skinadjacent to the incision, according to an exemplary embodiment of thepresent disclosure;

FIG. 14 is an illustration depicting opening of the inner bore of thetubular member and dissection tunnel using sterile retractors insertedinto the inner bore of the implant shield with the implant shield inplace to provide a shielded path for the implant to the implant pocketor dissection tunnel, according to an exemplary embodiment of thepresent disclosure;

FIG. 15A is an illustration depicting insertion of the implant throughthe aperture of the base of the implant shield with the inner bore ofthe tubular member held open by sterile retractors inserted into theinner bore of the implant shield, according to an exemplary embodimentof the present disclosure;

FIG. 15B is an illustration depicting delivery of the implant throughthe aperture of the base of the implant shield with the dissectiontunnel held open by sterile retractors placed in the dissection tunneloutside the tubular member of the implant shield and between the wallsof the dissection tunnel and the outer surface of the tubular member,according to an exemplary embodiment of the present disclosure;

FIG. 16 is an illustration depicting disengagement of the lower surfaceof the base of the implant shield from the skin of the subject andremoval of the tubular member from the dissection tunnel, according toan exemplary embodiment of the present disclosure;

FIG. 17 is an illustration depicting insertion of the tubular member ofthe implant shield into an inframammary incision in skin of the subject,rather than the periareolar incision depicted in FIGS. 9-16 , accordingto an exemplary embodiment of the present disclosure;

FIG. 18 is an illustration depicting insertion of the terminus of aconical sleeve through the aperture of the base and into the inner boreof the tubular member while the inner bore of the tubular member is heldopen using sterile retractors placed inside the inner bore of thetubular member, according to an exemplary embodiment of the presentdisclosure;

FIG. 19 is an illustration depicting insertion of the terminus of aconical sleeve through the aperture of the base and into the inner boreof the tubular member while the dissection tunnel is held open bysterile retractors placed in the dissection tunnel between the walls ofthe dissection tunnel and the outer surface of the tubular member of theimplant shield, according to an exemplary embodiment of the presentdisclosure;

FIG. 20 is an illustration depicting insertion of an implant into aconical sleeve having a terminus disposed within the inner bore of thetubular member so that the implant may be delivered to the surgicalpocket while being shielded by the implant shield;

FIG. 21 is an illustration depicting the creation of an inframammaryincision in the breast of a subject; according to an exemplaryembodiment of the present disclosure;

FIG. 22 is an illustration depicting the opening of the inframammaryincision using two retractors, according to an exemplary embodiment ofthe present disclosure;

FIG. 23 is an illustration depicting insertion of the distal end of thetubular member of the implant shield into the dissection tunnelconnecting the inframammary incision to the surgically-created implantpocket, according to an exemplary embodiment of the present disclosure;

FIG. 24 is an illustration depicting further insertion of the tubularmember into the dissection tunnel, according to an exemplary embodimentof the present disclosure;

FIG. 25 is an illustration depicting engagement of the lower surface ofthe base of the implant shield with at least a portion of the skinadjacent to the incision, according to an exemplary embodiment of thepresent disclosure;

FIG. 26 is an illustration depicting opening of the inner bore of thetubular member and dissection tunnel using sterile retractors insertedinto the inner bore of the implant shield with the implant shield inplace to provide a shielded path for the implant to the implant pocketor dissection tunnel, according to an exemplary embodiment of thepresent disclosure;

FIG. 27A is an illustration depicting insertion of the implant throughthe aperture of the base of the implant shield with the inner bore ofthe tubular member held open by sterile retractors inserted into theinner bore of the implant shield, according to an exemplary embodimentof the present disclosure;

FIG. 27B is an illustration depicting delivery of the implant throughthe aperture of the base of the implant shield with the dissectiontunnel held open by sterile retractors placed in the dissection tunneloutside the tubular member of the implant shield and between the wallsof the dissection tunnel and the outer surface of the tubular member,according to an exemplary embodiment of the present disclosure;

FIG. 28 is an illustration depicting disengagement of the lower surfaceof the base of the implant shield from the skin of the subject andremoval of the tubular member from the dissection tunnel, according toan exemplary embodiment of the present disclosure;

FIG. 29 is a partial cross-sectional view of the periareolar insertionof an implant through the aperture of the base of an implant shieldengaged with the skin of a subject and through the tubular member of theimplant shield towards the implant pocket with the retractors holdingopen the dissection tunnel by being placed outside the tubular member,according to an exemplary embodiment of the present disclosure;

FIG. 30 is a partial cross-sectional view of the periareolar insertionof an implant through the aperture of the base of an implant shieldengaged with the skin of a subject and through the tubular member of theimplant shield towards the implant pocket with the retractors holdingopen the tubular member by being placed inside the inner bore of thetubular member, according to an exemplary embodiment of the presentdisclosure;

FIG. 31 is a partial cross-sectional view of the periareolar insertionof the implant shield into a distal portion of the dissection tunnelafter adjusting the predetermined length of the inner bore of thetubular member based on a measured length of the dissection tunnelconnecting the implant pocket to the periareolar incision on the skin ofthe subject, according to an exemplary embodiment of the presentdisclosure; and

FIG. 32 is a partial cross-sectional view of the inframammary insertionof an implant through the aperture of the base of an implant shieldengaged with the skin of a subject through the tubular member of theimplant shield into a distal portion of the dissection tunnel and theimplant pocket, according to an exemplary embodiment of the presentdisclosure.

DETAILED DESCRIPTION

It will be appreciated that numerous specific details are set forth inorder to provide a thorough understanding of the embodiments describedherein. However, it will be understood by those of ordinary skill in theart that the embodiments described herein can be practiced without thesespecific details. In other instances, methods, procedures and componentshave not been described in detail so as not to obscure the relatedrelevant feature being described. Also, the description is not to beconsidered as limiting the scope of the embodiments described herein.

The present disclosure provides apparatus, methods, and systems forinserting prosthesis implants into surgically-created implant pockets ina subject. The presently disclosed apparatus, methods, and systems maybe used to deliver any prosthesis implant into a surgically-createdimplant pocket in a subject. The present disclosure is further directedto methods, devices, and systems for preventing capsular contractureresulting from surgical insertion of prosthesis implants. The prosthesisimplant may include, for example, filled implants or pre-filledimplants, unfilled implants, saline implants, silicone gel implants,textured implants, smooth implants, highly cohesive silicone gelimplants, or oil-filled implants. The prosthesis implant may also be,for example, an implantable device, such as a pacemaker or a jointreplacement prosthesis, or the prosthesis implant may be a tissue graft,such as an allograft or an autograft.

In some specific instances, the present disclosure is directed to theinsertion of breast implants into the implant pocket in a breast of asubject. In such cases, the breast implant may be an un-filled breastimplant or may be a pre-filled breast implant such as a pre-filledsaline implant or a pre-filled silicone implant. In particular, thepresently disclosed apparatus, methods, and systems are well-suited tothe delivery of pre-filled breast implants which require an insertiondevice capable of withstanding and managing the compressive andfrictional forces associated with insertion of the pre-filled implantwhile still being gentle enough so as to not damage the pre-filledimplant during delivery to the implant pocket in the subject. The breastimplant may also be, for example, a textured breast implant, a smoothbreast implant, a highly cohesive silicone gel breast implant, anoil-filled breast implant, or an un-filled saline breast implant. Thepresent disclosure is further directed to methods, devices, and systemsfor preventing capsular contracture resulting from surgical insertion ofbreast implants.

According to at least one aspect of the present disclosure, an apparatusfor inserting an implant into a surgically-created implant pocket in asubject is provided. The apparatus may include a base having an uppersurface and a lower surface. The base may have an aperture formedtherein which extends through the upper surface and the lower surface ofthe base. The apparatus may also include a tubular member that iscoupled to the base. The tubular member may have an inner bore extendinglongitudinally between a proximal end and a distal end. The inner boremay extend a predetermined length away from the lower surface of thebase. The proximal end of the tubular member may be coupled with thebase and the inner bore may be substantially aligned with the apertureformed in the base. The inner bore of the tubular member may be operableto receive the implant and has a substantially uniform cross-sectionalwidth over the predetermined length.

According to another aspect of the present disclosure, an apparatus forinserting an implant into a surgically-created implant pocket in asubject is provided. The apparatus includes a base having an uppersurface and a lower surface. The apparatus also includes a tubularmember extending through the base. The tubular member has an inner bore,a proximal end and a distal end. The inner bore of the tubular memberextends longitudinally a predetermined length away from the lowersurface of the base and between the proximal end and the distal end. Theinner bore is operable to receive an implant therethrough and has asubstantially uniform cross-sectional width over the predeterminedlength.

The presently disclosed apparatus may also be used to prevent capsularcontracture in a subject resulting from surgical insertion of a breastimplant in a surgically-created implant pocket through a dissectiontunnel connecting the implant pocket to an incision on the skin of thesubject. The apparatus is capable of shielding the implant frommicrobial contamination, including contamination by the endogenous floraof the subject, during insertion of the implant into thesurgically-created implant pocket.

According to at least one aspect of the present disclosure, a system isprovided. The system includes an apparatus for inserting an implant intoa surgically-created implant pocket in a subject as described herein.The system further includes an implant that may be inserted by theapparatus.

According to at least one other aspect of the present disclosure, asystem is provided. The system includes an apparatus for inserting animplant into a surgically-created implant pocket in a subject asdescribed herein. The system further includes a conical sleeve having aninterior cavity, a first terminus, and a second terminus. The firstterminus of the conical sleeve has a larger diameter than the secondterminus. The second terminus is operable to be inserted into theaperture of the base or inner bore of the tubular member of theapparatus. The conical sleeve is further operable to receive an implantinto its interior cavity via the first terminus and deliver the implantthrough the second terminus into the aperture of the base or the innerbore of the tubular member of the apparatus. In at least some instances,the system further includes an implant that may be inserted by theconical sleeve.

According to at least one aspect of the present disclosure, a kit isprovided. The kit includes an apparatus for inserting an implant into asurgically-created implant pocket in a subject, as described herein.Packaged together with the apparatus, the kit further includes animplant that may be inserted by the apparatus.

According to at least one other aspect of the present disclosure, a kitis provided. The kit includes an apparatus for inserting an implant intoa surgically-created implant pocket in a subject as described herein.The kit further includes a conical sleeve packaged together with theapparatus. The conical sleeve has an interior cavity, a first terminus,and a second terminus. The first terminus of the conical sleeve has alarger diameter than the second terminus. The second terminus isoperable to be inserted into the aperture of the base or the inner boreof the tubular member of the apparatus. The conical sleeve is furtheroperable to receive an implant into its interior cavity via the firstterminus and deliver the implant through the second terminus into theaperture of the base or the inner bore of the tubular member of theapparatus. In at least some instances, the kit further includes animplant packaged together with the apparatus and the conical sleeve. Theimplant is capable of being inserted by the conical sleeve.

According to at least one aspect of the present disclosure, a method forinserting an implant into a surgically-created implant pocket in asubject through a dissection tunnel connecting the implant pocket to anincision on the skin of the subject is disclosed. The method may includeproviding a sterile biofilm protection implant shield. The implantshield may include a base having an upper surface and a lower surface.The base may further have an aperture formed therein and extendingthrough the upper surface and the lower surface. The implant shield mayalso have a tubular member coupled with the base. The tubular member mayhave an inner bore extending longitudinally between a proximal end and adistal end. The inner bore may extend a predetermined length away fromthe lower surface of the base. The proximal end of the tubular membermay be coupled with the base and the inner bore may be substantiallyaligned with the aperture formed in the base. The inner bore may beoperable to receive the implant therethrough and may have asubstantially uniform cross-sectional width over the predeterminedlength. The method may further include inserting the distal end of thetubular member of the implant shield through the incision in the skin ofsubject and into the dissection tunnel such that the distal end of thetubular member is received in at least a portion of the dissectiontunnel or the implant pocket. The method may further include causing thelower surface of the base to substantially engage with at least aportion of the skin adjacent to an incision leading to the implantpocket. The method may also include delivering the implant to theimplant pocket by inserting the implant through the aperture of the baseand through the inner bore and distal end of the tubular member to theimplant pocket. The method may also be used to prevent capsularcontracture in a subject resulting from surgical insertion of a breastimplant in a surgically created implant pocket through a dissectiontunnel connecting the implant pocket to an incision on the skin of thepatient.

FIG. 1 depicts an isometric view of a biofilm protection implant shieldapparatus 100 for inserting an implant into a surgically-created implantpocket in a subject, according to an exemplary embodiment of the presentdisclosure. As depicted in FIG. 1 , implant shield 100 may include abase 175 having an upper surface 125 and a lower surface 135. Theimplant shield 100 includes an aperture 120 (not shown in FIG. 1 ; seeFIG. 4 ) formed in the base 175 and extending through the upper surface125 and the lower surface 135.

Implant shield 100 further includes a tubular member 150 coupled withthe base 175. The tubular member 150 has an inner surface 105, an outersurface 110, a proximal end 151 and a distal end 152. As depicted inFIG. 1 , the proximal end 151 is coupled with the base 175 while thedistal end 152 of tubular member 150 extends away from the base 175. Thetubular member 150 has an inner bore 115 defined by inner surface 105.The outer surface 110 defines an outer bore 195 of tubular member 150that includes the cross-sectional width of the inner bore 115 as well asthe thickness of the wall of the tubular member 150 at the particularportion along the outer surface 110 that the outer bore 195 isdetermined. The distal end 152 of the tubular member 150 has an aperture155 that is substantially aligned with inner bore 115 and aperture 120of the base 175 when the tubular member 150 is extended. As shown inFIG. 1 , the inner bore 115 has a longitudinal axis 160 extendingtherethrough. The longitudinal axis 160 extends substantiallyperpendicular to the base 175. The inner bore 115 extends longitudinallyalong the longitudinal axis 160 between the proximal end 151 and thedistal end 152 a predetermined length 165 (not shown in FIG. 1 ; seeFIG. 2 ) away from the lower surface 135 of the base 175. Therefore, thetubular member 150 also extends along the longitudinal axis 160 andsubstantially orthogonally from the base 175.

As depicted in FIG. 1 , the base 175 extends away from tubular member150 in a direction substantially perpendicular to the longitudinal axis160. The inner bore 115 is substantially aligned with the aperture 120formed in the base 175. In at least some instances, the base 175 extendsaway from tubular member 150 in substantially the same plane as theaperture 120. The aperture 120 and inner bore 115 of tubular member 150are operable to receive the implant. The proximal end 151 of tubularmember 150 is also operable to receive an implant therethrough. Thedistal end 152 of tubular member 150 is operable to be inserted into anincision in the skin of the subject and further operable to be extendedthe predetermined length 165 such that the distal end 152 is receivedinto at least a portion of the surgically-created implant pocket or adistal portion of the dissection tunnel connecting an incision in theskin of the subject to the implant pocket. In some instances, at least aportion of the inner bore 115 of the tubular member 150 may extend asecond predetermined length above the upper surface 125 of the base 175(not shown in FIGS. 1-4 ).

The tubular member 150 of biofilm protection implant shield apparatus100 is operable to extend along at least a portion of the dissectiontunnel during use. The tubular member 150 is also operable to deliverthe implant to the implant pocket or a distal portion of the dissectiontunnel without the implant contacting the incision site or at least aportion of the dissection tunnel. In some instances, the tubular member150 of apparatus 100 may be operable to shield the implant from touchingany portion of the dissection tunnel or incision site.

The inner bore 115 has a substantially uniform cross-sectional width 157over the predetermined length 165, as depicted in FIG. 2 . In at leastsome instances, the tubular member 150 and/or inner bore 115 issubstantially cylindrical in cross-sectional shape. In some instances,the tubular member 150 and/or inner bore 115 may be elliptical incross-sectional shape. In some cases, the inner bore 115 of tubularmember 150 is not tapered along the predetermined length 165. In atleast some instances, the distal end 152 has substantially the samecross-sectional width as the cross-sectional width of the proximal end151. In such cases, the cross-sectional width 157 of the inner bore 115at the distal end 152 of the tubular member 150 is substantially thesame as the cross-sectional width 157 of the inner bore 115 at theproximal end 151 of the tubular member. In some cases, the aperture 155of the distal end 152 of tubular member 150 has substantially the samecross-sectional width as the cross-sectional width of aperture 120 inbase 175. In some cases, the cross-sectional width of the aperture 120in base 175 may be substantially the same as the cross-sectional width157 of the inner bore 115 of the tubular member 150.

The cross-sectional width 157 of the inner bore 115 of the tubularmember 150 may be any cross-sectional width suitable to receive andfacilitate insertion of an implant into the implant pocket of a subject.For example, the cross-sectional width 157 of the inner bore 115 of thetubular member 150 may be from about 3 cm to about 12 cm, or from 3.5 cmto about 9 cm, or from about 3.5 cm to about 8.5 cm, or from about 5 cmto about 8 cm. In at least some instances, the cross-sectional width 157of the inner bore 115 may be selected based on the size of the implant.In general, pre-filled breast implants are from about 9 cm to about 16cm (most commonly from about 11 cm to about 12 cm) in diameter butdeform and elongate when inserted into the aperture 120 and inner bore115 of apparatus 100.

As used herein, the term “cross-sectional width” shall include thelongest distance between two points on the circumference or edge of thecross-section of an object having a circular and/or non-circularcross-section. The two points may be located on the interior or exteriorsurface circumference or edge of the cross-section of the object. Itshould be recognized that “cross-sectional width” of objects having asubstantially circular cross-section may be referred to as the“diameter” of the object. The terms “cross-sectional width” and“diameter” may be used interchangeably for objects having asubstantially circular cross-section. Understanding that the presentlydisclosed devices and apparatus, or portions thereof, may be deformableor collapsible or formed from collapsible or deformable materials, thecross-sectional width, as referred to herein, is generally measured inthe open and/or extended configuration, such as that typical during use.

While FIGS. 1-4 depict the inner bore 115 of the tubular member 150 assubstantially circular in cross-sectional profile, inner bore 115 mayhave any cross-sectional profile, including conical, elliptical, oval,or circular. Likewise, the outer bore 195 or outer profile of thetubular member 150, as defined by outer surface 110 of the tubularmember 150, may be conical, elliptical, oval, or circular. In at leastsome instances the distal end 152 and the proximal end 151 of inner bore115 have the same cross-sectional profile, wherein the cross-sectionalprofile is selected from the group consisting of circular, elliptical,and oval. For example, in cases in which the distal end 152 and theproximal end 151 of inner bore 115 have the same cross-sectionalprofile, the cross-sectional profile of both the distal end 152 and theproximal end 151 of inner bore 115 could have an ellipticalcross-sectional profile, or both could have a circular cross-sectionalprofile, or both could have an elliptical cross-sectional profile. Inother cases, the distal end 152 of inner bore 115 may have across-sectional profile that is different than the cross-sectionalprofile of the proximal end 151. For example, in such cases, the distalend 152 may have a cross-sectional profile that is elliptical while theproximal end 151 may have a circular cross-sectional profile. In casesin which the distal end 152 and the proximal end 151 of inner bore havedifferent cross-sectional profiles, they may still have thesubstantially the same cross-sectional width. It should be recognizedthat when the cross-sectional profile of a portion of the inner bore 115is circular, elliptical, or oval, the three-dimensional profile (e.g.,the exterior profile or shape) of a corresponding portion of tubularmember 150 may also be, respectively, circular, elliptical, or oval.

According to at least one aspect of the present disclosure, the base 175is operable to engage the skin of the subject so as to enable thetubular member 150 to stay in place during implant insertion as well asto enable the tubular member 150 to better resist the frictional forcescreated by insertion of the implant into the inner bore 115 so that thetubular member 150 is operable to shield the implant from the dissectiontunnel during transit of the implant along the inner bore to the implantpocket. The lower surface 135 of base 175 is operable to engage the skinof the subject adjacent to an incision so as to resist movement of thebase 175 when the implant is inserted into the aperture 120 and theinner bore 115 of tubular member 150. During use, the aperture 120 andinner bore 115 of tubular member 150 substantially overlies at least aportion of the incision. In at least some instances, the lower surface135 is operable to frictionally engage the skin of a subject. In suchcases, the frictional engagement resists movement of the base 175relative to the skin of the subject during use. In at least someinstances, the lower surface 135 may include a textured surface.

In some cases, the lower surface 135 may include a surface operable toengage the skin of a subject once it is wetted with a liquid or a fluid.In such cases, the liquid may be, for example, an aqueous solution,water, a saline solution, or any combination thereof. Other liquids orfluids may also be used to wet the lower surface 135 so long as thewetting of the lower surface by that liquid or fluid provides forsufficient engagement of lower surface 135 with the skin of the subjectsuch that movement of the base 175 is resisted during use. In at leastsome instances, the liquid or fluid may be disposed on the lower surface135 of base 175 or may be applied or otherwise disposed on the skin ofthe subject.

In other cases, an adhesive may be disposed on the lower surface 135.Any adhesive may be used so long as the adhesive provides for sufficientengagement of lower surface 135 with the skin of the subject such thatmovement of the base 175 is resisted during use. In some instances, theadhesive may be applied to the skin of the subject prior to engagementof the lower surface 135 of base 175 with the skin of the subject.

In at least some instances, a removable backing (not shown in FIGS. 1-4) may be included on the lower surface 135 of base 175. The removablebacking may serve to protect or otherwise keep clean the lower surface135 prior to use. In instances in which an adhesive is disposed on thelower surface 135, the removable backing may cover and protect theadhesive prior to use.

The tubular member 150 is operable to deliver the implant subdermally tothe implant pocket, or a distal portion of the dissection tunnel,through the predetermined length 165 of inner bore 115 of the tubularmember 150. In at least some instances, the predetermined length 165 maybe determined based on a distance between an incision in the skin of apatient and a surgically-created implant pocket formed below the skin.In other cases, the predetermined length 165 may be based on a distancebetween an incision in the skin and the length of the dissection tunnelor portion of a dissection tunnel connecting the incision to thesurgically-created implant pocket. In some instances, the predeterminedlength 165 between the proximal end 151 and the distal end 152 extendsthe inner bore 115 operably to deliver an implant subdermally throughthe aperture 120 and inner bore 115 and into the surgically-createdimplant pocket or a distal portion of the dissection tunnel or when thelower surface 135 of base 175 is adjacently engaged with the skin of asubject and the distal end 152 is received into at least a portion ofthe implant pocket or distal portion of the dissection tunnel.

The predetermined length 165 of the inner bore 115 of the tubular member150 may be adjusted based on the desired depth of insertion into thedissection tunnel, the size of the implant used, the location of theincision, and the characteristics of the subject's breast. In at leastsome instances, the predetermined length 165 of the inner bore 115 mayhave a predetermined length 165 equal to or less than the measuredlength of the dissection tunnel. In some instances, the predeterminedlength 165 of the inner bore 115 of the tubular member 150 may begreater than 1 cm, or greater than 1.5 cm, or greater than 2 cm, orgreater than 2.5 cm, or greater than 3 cm, or greater than 3.5 cm, orgreater than 4 cm, or greater than 4.5 cm, or greater than 5 cm, orgreater than 5.5 cm, or greater than 6 cm, or greater than 6.5 cm, orgreater than 7 cm, or greater than 7.5 cm, or greater than 8 cm. Inother instances, the predetermined length 165 may be from about 2 cm toabout 10 cm, or from about 3 cm to about 10 cm, or from about 2 cm toabout 8 cm, or from about 2 cm to about 5 cm, or from about 3 cm toabout 8 cm.

Biofilm protection implant shield apparatus 100, including tubularmember 150 and base 175, may be made of any suitable flexible material.For example, the flexible material may include, but is not limited to,plastic-containing fabrics, polymers, plastics, mylar, vinyls, polyvinylchloride, ethylene and alpha-olefin copolymers, silicone, solidsilicone, silicone rubber, and any combination thereof. In some cases,the tubular member 150 and base 175 may be formed from the samematerial. In some instances, the flexible material may be resistant tostretching. In some instances, the tubular member 150 and the base 175may be integrally formed. In some instances, the flexible material maybe a transparent or semi-transparent flexible material.

In other instances, biofilm protection implant shield apparatus 100,including tubular member 150 and base 175, may be stretchable and/ormade of a flexible material that is stretchable. As used herein, theterm “stretchable” refers to a material, or property of a device ordevice component, that may be extensible or elastomeric. That is, astretchable material, or a stretchable device or device component, maybe extended, deformed, or the like, without breaking, and may or may notsignificantly retract after removal of an extending force. As usedherein, the terms “elastomeric” or “elastic” are used interchangeably torefer to that property of a material (or device or device component)where upon removal of an elongating force, the material (or device ordevice component) is capable of recovering to substantially isunstretched size and shape or the material exhibits a significantretractive force. As used herein, the term “extensible” refers to thatproperty of a material (or device or device component) where uponremoval of an elongating force, the material (or device or devicecomponent) experiences a substantially permanent deformation or thematerial does not exhibit a significant retractive force.

In particular, tubular member 150 may be stretchable and/or comprise astretchable material. Stretchability of the tubular member 150 providesthe advantage that when retractors are placed inside of the tubularmember 150 during use to open up the dissection tunnel, the tubularmember 150 may stretch to allow greater opening of the dissection tunnelas well as engagement of the walls of the dissection tunnel therebyproviding effective shielding for the implant as well as reducing thefrictional forces associated with implant insertion. The stretchabilityof the tubular member 150 also provides the advantage of stretchingduring insertion of the implant so as to reduce the forces associatedwith implant insertion and to facilitate transit of the implant to theimplant pocket while providing the implant shielding function, whetherretractors are placed within tubular member 150 during use or not. In atleast some instances, the tubular member 150 may be elastic or comprisean elastic material. In other instances, the tubular member 150 may beextensible or comprise an extensible material.

In at least some instances, the tubular member 150 may be made of amaterial that is different than the material that makes up the base 175.For example, while it is advantageous in at least some instances thatthe tubular member be stretchable or made of a stretchable material,base 175 does not necessarily need to be stretchable or made of astretchable material. In other instances, base 175 may comprise the samematerial as tubular member 150 but the stretchability of tubular member150 is determined by the thickness of the material. In other words,tubular member 150 may be constructed of a material that is thin enoughto be stretchable during use while the base 175 may be constructed ofthe same material but may not be stretchable due to the chosen thicknessof the base 175.

In some cases, the inner bore 115 may include a lubricant along theinner surface 105 that defines the inner bore 115. In such cases, thelubricant along the inner surface 105 of the inner bore 115 mayfacilitate insertion and passage of the implant into and throughaperture 120 and inner bore 115. In some instances, the outer surface110 of the tubular member 150 may include a lubricant. In such cases,the lubricant on the outer surface 110 may facilitate insertion of thetubular member 150 into the dissection tunnel. The lubricant may be, forexample, a sterile lubricant selected from the group consisting of asurgical lubricant, a water-based lubricating jelly, a dry lubricant, apowdered lubricant, a moisture-activated lubricant, and any combinationthereof. The lubricant may be disposed on the inner surface 105 and/orthe outer surface 110 at the time of manufacturing and packing. In otherinstances, the lubricant may be applied to the inner surface 105 and/orthe outer surface 110 by a physician or technician prior to use so longas the surfaces and the lubricant remain sterile.

In some instances, the inner bore 115 or inner surface 105 of tubularmember 150 may include a lubricating coating or a friction-reducingcoating that serves a similar function as the lubricant described above.In some cases, the outer surface 110 of the tubular member 150 mayinclude a lubricating coating or a friction-reducing coating that alsoserves the same or similar function as the lubricant described above.

FIG. 2 is a planar view of the biofilm protection implant shieldapparatus 100, according to an exemplary embodiment of the presentdisclosure. As depicted in FIG. 2 , biofilm protection implant shieldapparatus 100 includes base 175 and tubular member 150 extending throughthe base 175 to form aperture 120 (not shown in FIG. 2 ; see FIG. 4 ).The tubular member 150 has an inner bore 115, a proximal end 151 and adistal end 152. The base 175 radially extends from at least a portion ofthe proximal end 151 of tubular member 150. The inner bore 115 has alongitudinal axis 160 therethrough which extends substantiallyperpendicular and/or orthogonally to the base 175. As shown in FIG. 2 ,the inner bore 115 extends longitudinally a predetermined length 165away from the lower surface 135 of the base 175 and between the proximalend 151 and the distal end 152. The tubular member 150 likewise extendsalong the longitudinal axis 160 a predetermined length 165 away from thelower surface 135 of the base 175 and substantially perpendicular and/ororthogonally to the base 175.

FIG. 3 is a front diagrammatic view of the biofilm protection implantshield apparatus 100 showing the distal end 152 of tubular member 150and the lower surface 135 of the base 175, according to an exemplaryembodiment of the present disclosure. As depicted in FIG. 3 , theproximal end 151 of tubular member 150 is coupled with base 175 of thebiofilm protection implant shield apparatus 100. The distal end 152 ofthe tubular member 150 comprises aperture 155 through which an implantmay exit after transiting through at least a portion of the dissectiontunnel during delivery to the implant pocket. FIG. 4 is a reardiagrammatic view of the biofilm protection implant shield apparatus 100showing base 175 having an aperture 120 formed therein and extendingthrough the upper surface 125 and the lower surface 135.

The base 175 can have any shape, configuration, diameter, or thicknessso long as the base 175 is operable to substantially engage with atleast a portion of the skin adjacent to an incision leading to theimplant pocket, and/or is operable to engage the skin of the subjectadjacent to an incision so as to resist movement of the base 175 whenthe implant is inserted into the aperture 120 and the inner bore 115 oftubular member 150, and/or is operable to substantially protect theimplant from contamination from the microbial flora that may be presenton the skin of the subject during insertion of the implant into theaperture 120 and the inner bore 115 of tubular member 150. For example,in at least some instances, the base 175 may be substantiallyrectangular as shown in FIGS. 1-4 , or the base 175 may be, for example,substantially circular as shown in FIG. 5 .

As depicted in FIG. 2 , the base 175 may have a diameter 167. As usedherein, the diameter 167 of base 175 is defined as the minimum distancebetween two opposite outer edges of the base 175 when the base 175 isfully extended away from the tubular member 150 (e.g., the same positionor configuration as when the base is engaged with the skin of thesubject). For example, as shown in FIG. 2 , the diameter 167 of base 175is the distance between first outer edge 136 and an opposite secondouter edge 137. The base 175 may have any diameter sufficient to beoperable to engage the skin of the subject and to resist movement of thebase 175 when the implant is inserted into the aperture 120 and theinner bore 115 of the tubular member 150. The base 175 may also have anydiameter sufficient to substantially protect the implant fromcontamination from the microbial flora that may be present on the skinof the subject during insertion of the implant into aperture 120. In atleast some instances, the base 175 may have a diameter 167 that is atleast 3 times greater than the cross-sectional width 157 of the innerbore 115 of the tubular member 150 and/or the aperture 120 and/or theouter bore 195 of the tubular member 150. In other instances, the base175 may have a diameter 167 that is from about 3 times to about 5 timesthe cross-sectional width 157 of the inner bore 115 of the tubularmember 150 and/or the aperture 120 and/or the outer bore 195 of thetubular member 150. For example, if the cross-sectional width 157 of theinner bore 115 is 5 cm, then the diameter 167 of the base 175 may befrom about 15 cm to about 25 cm. In other instances, the diameter 167 ofbase 175 may be from about 9 cm to about 60 cm, or from about 10.5 cm toabout 45 cm, or from about 10.5 cm to about 42.5 cm, or from about 15 cmto about 24 cm, or from about 20 cm to about 32 cm, or from about 25 cmto about 40 cm.

The base 175 may also have a radial length 169, as shown in FIG. 2 . Asused herein, the radial length 169 of base 175 is defined as thedistance between an outer edge (e.g., outer edges 136,137) of the base175, when the base 175 is fully extended away from the tubular member150 (e.g., the same position or configuration as when the base isengaged with the skin of the subject), and the outer surface 110 of theproximal end 151 of the tubular member 150 where it is coupled to thebase 175. Accordingly, the radial length 169 of the base 175 is thelength that the base 175 extends away from the tubular member 150. Thebase 175 may have any radial length sufficient to be operable to engagethe skin of the subject and to resist movement of the base 175 when theimplant is inserted into the aperture 120 and the inner bore 115 of thetubular member 150. The base 175 may also have any radial lengthsufficient to substantially protect the implant from contamination fromthe microbial flora that may be present on the skin of the subjectduring insertion of the implant into aperture 120. In at least someinstances, the base 175 may have a radial length 169 that is greaterthan or equal to the cross-sectional width 157 of the inner bore 115 ofthe tubular member 150 and/or the aperture 120 and/or the outer bore 195of the tubular member 150. In other instances, the base 175 may have aradial length 169 from about one (1) to about two (2) times thecross-sectional width 157 of the inner bore 115 of the tubular member150 and/or the aperture 120 and/or the outer bore 195 of the tubularmember 150. For example, if the cross-sectional width 157 of the innerbore 115 is 5 cm, then the radial length 169 of the base 175 may be fromabout 5 cm to about 10 cm. In other instances, the radial length of base175 may be from about 3 cm to about 12 cm, or from about 3.5 cm to about18 cm, or from about 3.5 cm to about 17 cm, or from about 5 cm to about8 cm, or from about 10 cm to about 16 cm, or from about 5 cm to about 16cm.

Base 175 may have sufficient thickness to provide structural support orrigidity to the biofilm protection implant shield apparatus 100 suchthat the implant may be easily inserted into aperture 120 and such thatthe base sufficiently resists the forces associated with implantinsertion to provide stability for the tubular member 150 when the base175 is engaged with the skin of the subject. Base 175 may also havesufficient thickness to provide enough structural support and rigidityto resist movement of the base relative to the skin of the subject, towhich the base 175 is engaged, during insertion of the implant intoaperture 120 and passage of the implant through the inner bore 115 ofthe tubular member 150. In some instances, the base 175 may have athickness (e.g., the distance or thickness between the lower surface 135and the upper surface 125 of base 175) that is substantially the same asthe thickness of the tubular member 150. In other instances, the base175 may have a thickness that is substantially thicker than thethickness of the tubular member 150. In other instances, the base 175may have a thickness that is substantially thinner than the thickness ofthe tubular member 150. In such instances, the tubular member 150 may bethicker than the thickness of the base 175 so that the tubular member150 has sufficient rigidity or structural integrity to facilitateinsertion into the dissection tunnel while resisting the forces createdby insertion of the implant into the inner bore 115 such that thetubular member 150 is operable to shield the implant from the dissectiontunnel during transit of the implant along the inner bore to the implantpocket.

Importantly, base 175 operably engages with the skin of the subject suchthat apparatus 100 does not need to be held by a surgeon or assistantduring insertion of the implant into aperture 120 and inner bore 115,even during insertion of pre-filled breast implants which areaccompanied by much higher forces of insertion. Apparatus 100 isparticularly suited to the delivery of pre-filled breast implantsbecause base 175 is operable to protect the implant from contaminationfrom the skin while stabilizing the tubular member 150 and resistingmovement during pre-filled implant insertion, which is accompanied bylarge compressional and frictional forces associated with deformation ofthe pre-filled implant during insertion and transit along the length ofthe inner bore 115 to the implant pocket. Base 175 does not displacefrom the skin of the subject during implant insertion even duringinsertion of pre-filled implants and when the base 175 or any otherportion of the device is not held by a surgeon or assistant.

In some instances, apparatus 100 may include a tubular member 150 thatis operable to form a base 175 or otherwise deploy or transition to forma base 175. For example, as shown in FIGS. 6A and 6B, the proximal end151 of tubular member 150 may be operable to be folded or rolled onitself to form a base 175. In such instances, the base 175 may be formedfrom successive folds of the proximal end 151 of tubular member 150, asshown in FIG. 6B. Other configurations may be possible in which thetubular member 150 may be deployed or transitioned to form a base 175.All such configurations in which the tubular member 150 may betransitioned from the undeployed configuration shown in FIG. 6A to thedeployed configuration shown in FIG. 6B having a suitable base 175formed from the tubular member 150 are within the scope and spirit ofthe present disclosure. In at least some instances the length of theinner bore 115 of tubular member 150 may be adjusted by forming the base175 such that the inner bore 115 has a predetermined length equal to orgreater than the length of the dissection tunnel.

As depicted in FIGS. 7A-7C, apparatus 100 may include a tubular member150 that is perforated or perforable at the proximal end 151 such thatthe tubular member 150 is operable to form a base 175 or otherwisedeploy or transition to form a base 175 by the deployment or splayingout of a plurality of flanges 177. FIG. 7A depicts device 100 in theundeployed configuration in which the plurality of flanges 177 aresubstantially parallel to the longitudinal axis 160. As shown in FIG.7A, the proximal end 151 of tubular member 150 may comprise a pluralityof flanges 177. In at least some instances, a plurality of flanges 177may be integrally formed on the proximal end 151 of tubular member 150.In some cases, the proximal end 151 of tubular member 150 may beperforated or scored so that a plurality of flanges 177 may be easilyseparated or formed upon tearing of the perforations or scored portionsof tubular member 150, be operable to be folded or rolled on itself toform a base 175.

FIGS. 7B and 7C depict apparatus 100 in the deployed configuration inwhich the plurality of flanges 177 are splayed out to form base 175 bytransitioning from the tubular arrangement in FIG. 7A to the basearrangement in FIG. 7B. As depicted in FIG. 7B, the plurality of flanges177 extend outward from tubular member 150 such that flanges 177 areperpendicular to the tubular member 150. FIG. 7C depicts thetransitioning of the plurality of flanges 177 from the tubulararrangement depicted in FIG. 7A to the base arrangement in which theplurality of flanges 177 are substantially perpendicular to thelongitudinal axis 160. In at least some instances, an adhesive may bedisposed on the lower surface 135 of each of the plurality of flanges177. In some instances, the lower surface 135 of each of the pluralityof flanges 177 may also include a removable backing that serves toprotect or otherwise keep clean the lower surface 135 of each of theplurality of flanges 177 prior to use. In instances in which an adhesiveis disposed on the lower surfaces 135, the removable backing may coverand protect the adhesive prior to use.

The plurality of flanges 177 may have any shape so long as they areoperable to form base 175 as described herein. While the plurality offlanges 177 are depicted in FIGS. 7A-7C as substantially rectangular inshape, the plurality of flanges 177 may have any other shape including asubstantially trapezoidal shape depicted in FIGS. 8A-8C.

The present disclosure also provides a system that includes the biofilmprotection implant shield apparatus 100 and an implant capable of beinginserted by the biofilm protection implant shield apparatus. The presentdisclosure further provides a system that includes the biofilmprotection implant shield apparatus 100 and a conical sleeve. Theconical sleeve has an interior cavity, a first terminus, and a secondterminus. The first terminus of the conical sleeve has a larger diameterthan the second terminus. Therefore the conical sleeve is tapered alongits length. The second terminus of the conical sleeve is operable to beinserted into the aperture 120 or inner bore 115 of the tubular member150 of the apparatus 100. The conical sleeve is further operable toreceive an implant into its interior cavity via the first terminus anddeliver the implant through the second terminus into the inner bore 115of the apparatus 100 when the lower surface 135 of the base 175 isengaged with the skin of the subject. In at least some instances, thesystem further includes an implant that may be inserted by the conicalsleeve.

The present disclosure also provides a kit that includes the biofilmprotection implant shield apparatus 100 packaged together with animplant capable of being inserted by the biofilm protection implantshield apparatus. The present disclosure further provides a kit thatincludes the biofilm protection implant shield apparatus 100 packagedtogether with a conical sleeve. The conical sleeve has an interiorcavity, a first terminus, and a second terminus. The first terminus ofthe conical sleeve has a larger diameter than the second terminus.Therefore the conical sleeve is tapered along its length. The secondterminus of the conical sleeve is operable to be inserted into theaperture 120 or inner bore 115 of the tubular member 150 of theapparatus 100. The conical sleeve is further operable to receive animplant into its interior cavity via the first terminus and deliver theimplant through the second terminus into the inner bore 115 of theapparatus 100 when the lower surface 135 of the base 175 is engaged withthe skin of the subject. In at least some instances, the kit furtherincludes an implant that may be inserted by the conical sleeve.

The apparatus, systems, kits, and methods of the present disclosure maybe used with any implants. For example, the implant may be, but is notlimited to, filled implants, unfilled implants, saline implants,silicone gel implants, textured implants, smooth implants, highlycohesive silicone gel implants, oil-filled implants, and prosthesisimplants. The subject may be any subject in need of an implant. Thesubject may be, for example, but not limited to, a mammal or a human. Insome cases, the subject may be a human and the implant may be a breastimplant. While FIGS. 9-32 illustrate methods of using the presentlydisclosed apparatus and techniques of using the apparatus for insertinga breast implant into a human subject, one of skill in the art willunderstand and appreciated the depicted methods may be used for any typeof implant in any type of subject in need thereof. FIGS. 9-32 illustratemethods for inserting an implant into a surgically-created implantpocket in a subject using the biofilm protection implant shieldapparatus 100 disclosed herein. FIGS. 9-16, 18-20, and 29-31 depictmethods for use of the presently disclosed biofilm protection implantshield apparatus 100 in the case of a periareolar incision and implantinsertion, whereas FIGS. 17, 21-28, and 32 depict methods for use of theimplant shield apparatus 100 in the case of an inframammary incision andimplant insertion.

In order for the implant to be inserted into the surgically-createdimplant pocket it must first pass through the incision in the skin ofthe subject and through the dissection tunnel connecting the implantpocket to the incision. As depicted in FIG. 9 , a periareolar incision510 in the skin 501 of the subject is created by scalpel 515.

FIG. 10 depicts the use of retractors 651, 652 to open the periareolarincision 510 and to facilitate full surgical dissection of the implantpocket and the dissection tunnel connecting the implant pocket to theincision. Apparatus 100 is a shield rather than a retractor and is notcapable of dilating the incision or holding open the incision during uselike a retractor. However, unlike a retractor, the tubular member 150 ofapparatus 100 is much quicker and easier to insert into the incision anddissection tunnel and therefore requires less manipulation. The lessrequired manipulation and speed and ease of use of apparatus 100 resultsin less contamination risk to the implant and greater effectiveness ofbiofilm shielding. Additionally, since the distal end 152 of the tubularmember 150 does not include or require a retracting member, apparatus100 provides for easy adjustment of the predetermined length 165 priorto use by cutting the distal end 152 of the tubular member 150 to thedesired predetermined length 165. Apparatus 100 may be used inconjunction with separate retractors, such as retractors 651, 652 shownin FIG. 11 , which allows the dissection tunnel and implant pocket to beopened up and reduces the resistance of the implant to insertion as wellas reduces the external force required for insertion and delivery of theimplant to the implant pocket.

While FIG. 11 depicts the use of retractors during use of apparatus 100,one of skill in the art will understand that in other instances,apparatus 100 may be used without retractors particularly depending onthe type, nature, and size of the implant being inserted. Additionally,tubular member 150 may be stretchable or comprise a stretchable materialproviding for expansion of the dissection tunnel during insertion of theimplant into the stretchable tubular member 150. In such cases, thetubular member 150 may stretch to accommodate the implant as well as toengage the walls of the dissection tunnel so that the dissection tunnelis opened sufficient for implant insertion while the tubular member 150shields the implant from the dissection tunnel or a portion thereof. Thestretchability of the tubular member 150 also provides the advantagethat when retractors are placed inside of the tubular member 150 duringuse to open up the dissection tunnel, the tubular member 150 may stretchto allow greater opening of the dissection tunnel as well as engagementof the walls of the dissection tunnel thereby providing effectiveshielding for the implant as well as reducing the frictional forcesassociated with implant insertion. The stretchability of the tubularmember 150 also provides the advantage of stretching during insertion ofthe implant so as to reduce the forces associated with implant insertionand to facilitate transit of the implant to the implant pocket whileproviding the implant shielding function, whether retractors are placedwithin tubular member 150, placed between the tubular member 150 and thewalls of the dissection tunnel, or not used at all.

As depicted in FIG. 11 , the incision 510 and the dissection tunnel arefurther opened using retractors 651, 652 to facilitate insertion of thetubular member 150 of apparatus 100. In particular, the distal end 152of the tubular member 150 is inserted through the incision 510 and intothe dissection tunnel using any suitable sterile insertion tool, such asforceps 725. As shown in FIG. 12 , the tubular member 150 is furtherinserted into the dissection tunnel such that the distal end 152 of thetubular member 150 is received in at least a portion of the dissectiontunnel or the implant pocket.

The distal end 152 of the tubular member 150 is generally inserted intothe dissection tunnel to a depth greater than 1 cm below the incision soas to sufficiently shield the implant during insertion into thedissection tunnel and implant pocket. In general, it is not necessaryfor the tubular member 150 to shield the implant from the entire lengthof the dissection tunnel since often only a portion of the dissectiontunnel is formed through breast tissue (glandular tissue) which may becolonized by microbes, thereby posing a risk of microbial contaminationto the otherwise sterile implant. Often, the remaining portions of thedissection tunnel are formed through sterile muscle or adipose tissuethat do not pose a significant contamination risk to the implant duringits transit to the implant pocket. Generally, the upper dissectiontunnel comprises breast tissue and/or glandular tissue while the lowerdissection tunnel comprises tissue other than breast or glandulartissue, such as muscle or adipose tissue. As used herein, the upperdissection tunnel refers to the portion of the dissection tunnelbeginning at the incision in the skin of the patient and extendingdownward for so long as the walls of the dissection tunnel are formedthrough breast and/or glandular tissue. The lower dissection tunnel, asused herein, refers to the portion of the dissection tunnel beginning atthe first instance of tissue other than breast and/or glandular tissue,such as muscle or adipose tissue and extending to the implant pocket.Therefore, the upper dissection tunnel is the upper most portion of thedissection tunnel connecting the incision in the skin of the patient tothe lower dissection tunnel which in turn extends to the implant pocket.The length of the upper dissection tunnel can be measuredintraoperatively and used to determine the predetermined length of theinner bore 115 and tubular member 150. In at least some instances, thedistal end 152 of tubular member 150 is inserted into the dissectiontunnel such that the entire length of the upper dissection tunnel isshielded from the implant during transit of the implant to the implantpocket. In such cases, the distal end 152 is inserted into thedissection tunnel to a depth equal to or greater than the length of theupper dissection tunnel. In other instances, the distal end 152 may beinserted into the dissection tunnel such that at least a portion of theupper dissection tunnel is shielded from the implant during transit ofthe implant to the implant pocket.

In at least some instances, the distal end 152 of the tubular member 150is inserted greater than 1.5 cm, or greater than 2 cm, or greater than2.5 cm, or greater than 3 cm, or greater than 3.5 cm, or greater than 4cm, or greater than 4.5 cm, or greater than 5 cm, or greater than 5.5cm, or greater than 6 cm, or greater than 6.5 cm, or greater than 7 cm,or greater than 7.5 cm, or greater than 8 cm, below the incision. In atleast some instances, the distal end 152 of the tubular member 150 isinserted into the dissection tunnel to a depth of from about 2 cm toabout 10 cm, or from about 3 cm to about 10 cm, or from about 2 cm toabout 8 cm, or from about 2 cm to about 5 cm, or from about 3 cm toabout 8 cm, below the incision. The depth of insertion will generallydepend on the size of the implant used, the location of the incision,and the characteristics of the subject's breast. In at least someinstances, insertion of the implant into the tubular member 150 mayextend the distal end 152 of the tubular member 150 deeper into thedissection tunnel such that the implant is shielded from a greaterportion of the dissection tunnel during its transit to the implantpocket.

In at least some instances, the predetermined length 165 of the innerbore 115 of the tubular member 150 may be adjusted based on the desireddepth of insertion into the dissection tunnel. In such instances,intraoperative measurements of the length of the dissection tunnel maybe used to determine the predetermined length 165 of the inner bore 115of the tubular member 150 necessary to shield the implant from at leasta portion of the dissection tunnel. In such cases, the predeterminedlength 165 of the inner bore 115 may be adjusted or cut to apredetermined length 165 equal to or less than the measured length ofthe dissection tunnel.

Once the tubular member 150 is sufficiently inserted into the dissectiontunnel, the base 175 of apparatus 100 may be engaged with the surface ofthe skin 501 of the subject so that apparatus 100 may be anchored inplace during insertion of the implant. As shown in FIG. 13 , the lowersurface 135 (opposite of upper surface 125) of base 175 is engaged withthe skin 501 of the subject. As described above, the lower surface 135of the base 175 may be engaged with the skin 501 of the subject by anynumber of techniques, including, but not limited to, frictionalengagement by a textured surface or by wetting with a suitable liquidand by attaching to the skin 501 of the subject using an adhesiveexposed by the removal of a removable backing. Once apparatus 100 issecurely engaged with the skin 501 of the subject, aperture 120 andinner bore 115 substantially overlie at least a portion of the incision.In some instances, the distal end 152 of the tubular member 150 may befurther positioned by inserting the insertion tool or retractors throughthe aperture 120 of the base 175 and within the inner bore 115 oftubular member 150. In this manner, the distal end 152 may be furtherinserted such that it is sufficiently received in a portion of eitherthe dissection tunnel or the implant pocket.

In FIG. 14 , the aperture 120 and the inner bore 115 of the tubularmember 150 are opened up by sterile retractors 1001, 1002 so that theimplant 1100 may be inserted into the aperture 120 and inner bore 115 ofthe apparatus 100, as shown in FIGS. 15A and 15B. As depicted in FIGS.15A and 15B there are at least two methods by which the dissectiontunnel may be opened sufficient for implant insertion into the breast.In FIG. 15A, the retractors 1001, 1002 are placed through aperture 120and into inner bore 115 of the tubular member 150 in order to open thedissection tunnel and the inner bore 115 in order to facilitateinsertion of implant 1100. FIG. 15B depicts an alternative method inwhich retractors 1001, 1002 are placed in the dissection tunnel outsidethe tubular member 150 and in between the walls of the dissection tunneland the outer surface 110 of tubular member 150.

After the implant 1100 is inserted into the implant pocket while beingshielded from the endogenous flora of the subject by biofilm protectionimplant shield apparatus 100, as described above, the base 175 of theapparatus 100 may be disengaged from the skin 501 of the subject and thetubular member 150 may be withdrawn from the dissection tunnel, asdepicted in FIG. 16 . While FIGS. 9-16 depict the use of periareolarincision carrying out the presently disclosed methods and techniques,any suitable incision may be used and still be within the spirit andscope of the present disclosure. For example, the incision may be aperiareolar incision, an inframammary incision, an axillary incision, avertical incision, and a transumbilical incision, or any other incisionthat may be made for the purpose of breast implant insertion. FIG. 17depicts the non-limiting example of apparatus 100 used in the context ofan inframammary incision in the skin of a subject in which the lowersurface 135 (opposite of upper surface 125) of base 175 is engaged withthe skin 501 of the subject and aperture 120 and inner bore 115substantially overlie at least a portion of the inframammary incision.

FIGS. 18-20 depict an alternative embodiment for inserting the implant1100 into the aperture 120 of the tubular member 150 of implant shieldapparatus 100 once the lower surface 135 of the base 175 is engaged withthe skin 501 of the subject. As depicted in FIGS. 18-20 , a conicalsleeve 1800 may be used to deliver the implant 1100 through aperture 120and into inner bore 115 of tubular member 150. The conical sleeve 1800may have an interior cavity 1815, a first terminus 1805, and a secondterminus 1810, where the first terminus 1805 has a larger diameter thanthe second terminus 1810. The second terminus 1810 of conical sleeve1800 may be inserted into the aperture 120 and inner bore 115 of thetubular member 150 of apparatus 100, as depicted in FIG. 18 . Theconical sleeve 1800 is operable to receive implant 1100 into itsinterior cavity 1815 via the first terminus 1805 and deliver the implant1100 through the second terminus 1810 into the inner bore 115 ofapparatus 100, as shown in FIGS. 19-20 .

FIGS. 21-28 illustrate methods for the use of the presently disclosedbiofilm protection implant shield apparatus 100 in the case ofinframammary incision and implant insertion. As depicted in FIG. 21 , aninframammary incision 2110 in the skin 501 of the subject is created byscalpel 515. FIG. 22 depicts the use of retractors 651, 652 to open theinframammary incision 2110 and to facilitate full surgical dissection ofthe implant pocket and the dissection tunnel connecting the implantpocket to the incision. As depicted in FIG. 23 , the inframammaryincision 2110 and the dissection tunnel are further opened usingretractors 651, 652 to facilitate insertion of the tubular member 150 ofapparatus 100. In particular, the distal end 152 of the tubular member150 is inserted through the incision 2110 and into the dissection tunnelusing any suitable sterile insertion tool, such as forceps 725. As shownin FIG. 24 , the tubular member 150 is further inserted into thedissection tunnel such that the distal end 152 of the tubular member 150is received in at least a portion of the dissection tunnel or theimplant pocket.

Once the tubular member 150 is sufficiently inserted into the dissectiontunnel, the base 175 of apparatus 100 may be engaged with the surface ofthe skin 501 of the subject so that apparatus 100 may be anchored inplace during insertion of the implant. As shown in FIG. 25 , the lowersurface 135 (opposite of upper surface 125) of base 175 is engaged withthe skin 501 of the subject. As described above, the lower surface 135of the base 175 may be engaged with the skin 501 of the subject by anynumber of techniques, including, but not limited to, frictionalengagement by a textured surface or by wetting with a suitable liquidand by attaching to the skin 501 of the subject using an adhesiveexposed by the removal of a removable backing. Once apparatus 100 issecurely engaged with the skin 501 of the subject, aperture 120 andinner bore 115 substantially overlie at least a portion of the incision.In some instances, the distal end 152 of the tubular member 150 may befurther positioned by inserting the insertion tool or retractors throughthe aperture 120 of the base 175 and within the inner bore 115 oftubular member 150. In this manner, the distal end 152 may be furtherinserted such that it is sufficiently received in a portion of eitherthe dissection tunnel or the implant pocket.

In FIG. 26 , the aperture 120 and the inner bore 115 of the tubularmember 150 are opened up by sterile retractors 1001, 1002 so that theimplant 1100 may be inserted into the aperture 120 and inner bore 115 ofthe apparatus 100, as shown in FIGS. 27A and 27B. As depicted in FIGS.27A and 27B there are at least two methods by which the dissectiontunnel may be opened sufficient for implant insertion into the breast.In FIG. 27A, the retractors 1001, 1002 are placed through aperture 120and into inner bore 115 of the tubular member 150 in order to open thedissection tunnel and the inner bore 115 in order to facilitateinsertion of implant 1100. FIG. 27B depicts an alternative method inwhich retractors 1001, 1002 are placed in the dissection tunnel outsidethe tubular member 150 and in between the walls of the dissection tunneland the outer surface 110 of tubular member 150.

After the implant 1100 is inserted into the implant pocket while beingshielded from the endogenous flora of the subject by biofilm protectionimplant shield apparatus 100, as described above, the base 175 of theapparatus 100 may be disengaged from the skin 501 of the subject and thetubular member 150 may be withdrawn from the dissection tunnel, asdepicted in FIG. 28 .

FIGS. 29-32 are partial cross-sectional views illustrating methods forthe use of the presently disclosed biofilm protection implant shieldapparatus 100. In particular, FIG. 29 depicts periareolar insertion ofan implant 1100 through aperture 120 of base 175 of the implant shieldapparatus 100. As depicted in FIG. 29 , the lower surface 135 of base175 is engaged with the skin 501 of the subject while the dissectiontunnel 2910 is held open by retractors 1001, 1002 placed outside thetubular member 150 and between the outer surface 110 of the tubularmember 150 and the walls 2915 of dissection tunnel 2910. As shown inFIG. 29 , insertion of the implant 1100 through aperture 120 and intothe inner bore 115 of tubular member 150 provides for shielding of theimplant 1100 from contamination by the breast tissue 2975 comprising theupper dissection tunnel 2911 and the endogenous flora of the subjectduring transit through the dissection tunnel 2910 to the implant pocket2950. The lower dissection tunnel 2912 is formed by pectoral muscletissue 2980, as shown by FIG. 29 .

FIG. 30 depicts a similar periareolar insertion as shown in FIG. 29 ,except that retractors 1101, 1102, are placed inside of the inner bore115 of tubular member 150 so as to hold open the inner bore 115 duringinsertion of the implant 1100 through aperture 120 of tubular member150. As depicted in FIG. 30 , tubular member 150 having outer surface110 shields the implant 1100 from contamination by the breast tissue2975 and the endogenous flora of the subject during transit of theimplant 1100 through the dissection tunnel 2910 to the implant pocket2950.

FIG. 31 depicts insertion of the distal end 152 of tubular member 150into the dissection tunnel 2910 connecting a periareolar incision to theimplant pocket 2950. As shown in FIG. 31 , the distal end 152 of thetubular member 150 is generally inserted into the dissection tunnel to adepth greater than 1 cm below the incision so as to sufficiently shieldthe implant 1100 during insertion into the dissection tunnel 2910 andimplant pocket 2950. The tubular member 150 and inner bore 115 oftubular member 150 have a predetermined length 165 that may be adjusted(e.g., from about 1.5 cm to about 10 cm) based on the length of thedissection tunnel 2910, the desired depth of insertion into thedissection tunnel 2910, the size of the implant used, the location ofthe incision, and the characteristics of the subject's breast.

FIG. 32 depicts a partial cross-sectional view of the inframammaryinsertion of an implant 1100 through the aperture 120 of the base 175 ofan implant shield 100 engaged with the skin 501 of a subject. Asdepicted in FIG. 32 , the implant 1100 transits the inner bore 115 oftubular member 150 which shields the implant 1100 from at least aportion of the dissection tunnel 2910 as the implant 1100 exits theaperture 155 of the tubular member 150 and enters the implant pocket2950.

Statements of the Present Disclosure

Numerous examples are provided herein to enhance understanding of thepresent disclosure. A specific set of statements are provided asfollows.

Statement 1: An apparatus for inserting an implant into asurgically-created implant pocket in a subject, the apparatuscomprising: a base having an upper surface and a lower surface, the basehaving an aperture formed therein and extending through the uppersurface and the lower surface; and a tubular member coupled with thebase, the tubular member having an inner bore extending longitudinallybetween a proximal end and a distal end, the inner bore extending apredetermined length away from the lower surface of the base; whereinthe proximal end of the tubular member is coupled with the base and theinner bore is substantially aligned with the aperture formed in thebase; and wherein the inner bore is operable to receive the implanttherethrough and has a substantially uniform cross-sectional width overthe predetermined length.

Statement 2: The apparatus according to Statement 1, wherein the innerbore has a longitudinal axis therethrough, the tubular member extendingalong the longitudinal axis.

Statement 3: The apparatus according to Statement 1 or Statement 2,wherein the inner bore extends longitudinally along a longitudinal axisa predetermined length away from the lower surface of the base.

Statement 4: The apparatus according to Statement 2 or Statement 3,wherein the longitudinal axis extends substantially perpendicular to thebase.

Statement 5: The apparatus according to Statement 1, wherein the tubularmember extends longitudinally along a longitudinal axis substantiallyperpendicular to the base.

Statement 6: The apparatus according to any one of the precedingStatements 1-5, wherein the tubular member extends substantiallyorthogonally from the base.

Statement 7: The apparatus according to any one of the precedingStatements 1-6, wherein the base extends away from the tubular member ina direction substantially perpendicular to the longitudinal axis.

Statement 8: The apparatus according to any one of the precedingStatements 1-7, wherein the tubular member is substantially cylindricalin cross-sectional shape.

Statement 9: The apparatus according to any one of the precedingStatements 1-7, wherein the tubular member is elliptical incross-sectional shape.

Statement 10: The apparatus according to any one of the precedingStatements 1-9, wherein at least a portion of the inner bore of tubularmember extends a second predetermined length above the upper surface ofthe base.

Statement 11: The apparatus according to any one of the precedingStatements 1-10, wherein the lower surface of the base is operable toengage with a skin of the subject.

Statement 12: The apparatus according to any one of the precedingStatements 1-11, wherein the lower surface of the base is operable toengage a skin of the subject adjacent to an incision, wherein the innerbore of tubular member substantially overlies at least a portion of theincision.

Statement 13: The apparatus according to any one of the precedingStatements 1-12, wherein the lower surface of the base is operable toengage with a skin of the subject so as to resist movement of the basewith respect to the skin when engaged with the skin.

Statement 14: The apparatus according to any one of the precedingStatements 1-13, wherein the lower surface is operable to frictionallyengage the skin of a subject, wherein the frictional engagement resistsmovement of the base relative to the skin.

Statement 15: The apparatus according to any one of the precedingStatements 1-14, wherein the lower surface comprises a textured surface.

Statement 16: The apparatus according to any one of the precedingStatements 1-15, wherein the lower surface comprises a surface operableto frictionally engage the skin of a subject once wetted.

Statement 17: The apparatus according to any one of the precedingStatements 1-15, wherein a fluid is disposed on one of the lower surfaceand/or the skin of the patient, the fluid operable to form a frictionalengagement between the lower surface and the skin.

Statement 18: The apparatus according to any one of the precedingStatements 1-15, wherein an adhesive is disposed on the lower surface.

Statement 19: The apparatus according to Statement 18, wherein the lowersurface further comprises a removable backing, the removable backingoperable to expose the adhesive.

Statement 20: The apparatus according to any one of the precedingStatements 1-19, wherein the predetermined length is determined based ona distance between an incision in the skin of a patient and asurgically-created implant pocket formed below the skin.

Statement 21: The apparatus according to any one of the precedingStatements 1-20, wherein the predetermined length between the proximalend and the distal end extends the inner bore operably to deliver animplant subdermally through the aperture and inner bore and into thesurgically-created implant pocket when the lower surface of base isadjacently engaged with the skin of a patient and the distal end isreceived into at least a portion of the implant pocket.

Statement 22: The apparatus according to any one of the precedingStatements 1-21, wherein the proximal end of tubular member is operableto receive an implant therethrough.

Statement 23: The apparatus according to Statement 22, wherein thetubular member is further operable to deliver the implant subdermally tothe implant pocket through the predetermined length of inner bore of thetubular member.

Statement 24: The apparatus according to any one of the precedingStatements 1-23, wherein the distal end of tubular member is operable tobe inserted into an incision in the skin of the subject, and the tubularmember is operable to be extended the predetermined length such that thedistal end is received into at least a portion of the surgically-createdimplant pocket.

Statement 25: The apparatus according to Statement 24, wherein tubularmember extends along at least a portion of a dissection tunnel formedbetween the incision and the implant pocket.

Statement 26: The apparatus according to Statement 24 or Statement 25,wherein the tubular member is operable to deliver the implant to theimplant pocket through a dissection tunnel connecting the incision tothe implant pocket without the implant contacting the dissection tunnel.

Statement 27: The apparatus according to any one of the precedingStatements 1-26, wherein the tubular member comprises an inner surfaceand an outer surface, the inner surface defining the inner bore oftubular member.

Statement 28: The apparatus according to any one of the precedingStatements 1-27, wherein the tubular member and the base are formed fromthe same material.

Statement 29: The apparatus according to any one of the precedingStatements 1-28, wherein the tubular member and base are formed from aflexible material.

Statement 30: The apparatus according to Statement 29, wherein theflexible material is resistant to stretching.

Statement 31: The apparatus according to Statement 29, wherein theflexible material is capable of stretching.

Statement 32: The apparatus according to Statement 29, wherein theflexible material is operable to stretch when an implant is insertedand/or physically manipulated through the longitudinal length of theinner bore of the tubular member.

Statement 33: The apparatus according to any one of Statements 29-32,wherein the flexible material is selected from the group consisting ofplastic-containing fabrics, polymers, plastics, mylar, vinyls, polyvinylchloride, ethylene and alpha-olefin copolymers, silicone, solidsilicone, silicone rubber, and any combination thereof.

Statement 34: The apparatus according to any one of the precedingStatements 1-33, wherein the tubular member and the base are integrallyformed.

Statement 35: The apparatus according to any one of the precedingStatements 1-34, wherein the inner bore of tubular member is not taperedalong the predetermined length.

Statement 36: The apparatus according to any one of the precedingStatements 1-35, wherein the implant is selected from the groupconsisting of a breast implant, a pre-filled breast implant, apre-filled saline breast implant, a pre-filled silicone breast implant,an un-filled breast implant, a saline breast implant, a silicone breastimplant, a textured breast implant, a smooth breast implant, a highlycohesive silicone gel breast implant, an oil-filled breast implant, andan un-filled saline breast implant.

Statement 37: The apparatus according to any one of the precedingStatements 1-36, wherein the inner bore comprises a lubricant.

Statement 38: The apparatus according to any one of the precedingStatements 1-36, wherein the inner surface of the tubular membercomprises a lubricant.

Statement 39: The apparatus according to any one of the precedingStatements 1-36, wherein the outer surface of the tubular membercomprises a lubricant.

Statement 40: The apparatus according to any one of the precedingStatements 37-39, wherein the lubricant is a sterile lubricant selectedfrom the group consisting of a surgical lubricant, a water-basedlubricating jelly, a dry lubricant, a powdered lubricant, amoisture-activated lubricant, and any combination thereof.

Statement 41: The apparatus according to any one of the precedingStatements 1-40, wherein the inner bore comprises a lubricating coatingor a friction-reducing coating.

Statement 42: The apparatus according to any one of the precedingStatements 1-36, wherein the inner surface of the tubular membercomprises a lubricating coating or a friction-reducing coating.

Statement 43: The apparatus according to any one of the precedingStatements 1-36, wherein the outer surface of the tubular membercomprises a lubricating coating or a friction-reducing coating.

Statement 44: The apparatus according to any one of the precedingStatements 1-43, wherein the predetermined length of the inner bore isequal to or less than a measured length of the dissection tunnel.

Statement 45: The apparatus according to any one of the precedingStatements 1-43, wherein the predetermined length of the inner bore isequal to or less than a measured length of the upper dissection tunnel.

Statement 46: The apparatus according to any one of the precedingStatements 1-45, wherein the predetermined length of the inner bore isgreater than 1 cm.

Statement 47: The apparatus according to any one of the precedingStatements 1-45, wherein the predetermined length of the inner bore isgreater than 1.5 cm.

Statement 48: The apparatus according to any one of the precedingStatements 1-45, wherein the predetermined length of the inner bore isgreater than 2 cm.

Statement 49: The apparatus according to any one of the precedingStatements 1-45, wherein the predetermined length of the inner bore isgreater than 2.5 cm.

Statement 50: The apparatus according to any one of the precedingStatements 1-45, wherein the predetermined length of the inner bore isgreater than 3 cm.

Statement 51: The apparatus according to any one of the precedingStatements 1-45, wherein the predetermined length of the inner bore isgreater than 3.5 cm.

Statement 52: The apparatus according to any one of the precedingStatements 1-45, wherein the predetermined length of the inner bore isgreater than 4 cm.

Statement 53: The apparatus according to any one of the precedingStatements 1-45, wherein the predetermined length of the inner bore isgreater than 4.5 cm.

Statement 54: The apparatus according to any one of the precedingStatements 1-45, wherein the predetermined length of the inner bore isgreater than 5 cm.

Statement 55: The apparatus according to any one of the precedingStatements 1-45, wherein the predetermined length of the inner bore isfrom about 1.5 cm to about 10 cm.

Statement 56: The apparatus according to any one of the precedingStatements 1-45, wherein the predetermined length of the inner bore isfrom about 1.5 cm to about 5 cm or from about 3 cm to about 8 cm.

Statement 57: The apparatus according to any one of the precedingStatements 1-56, wherein the distal end of the tubular member comprisesa second aperture that is substantially aligned with the inner bore andthe aperture of the base when the tubular member is extended.

Statement 58: The apparatus according to any one of the precedingStatements 1-57, wherein the distal end has substantially the samecross-sectional width as the cross-sectional width of the proximal end.

Statement 59: The apparatus according to any one of the precedingStatements 1-58, wherein the cross-sectional width of the inner bore atthe distal end of the tubular member is substantially the same as thecross-sectional width of the inner bore at the proximal end of thetubular member.

Statement 60: The apparatus according to any one of the precedingStatements 57-59, wherein the second aperture at the distal end of thetubular member has substantially the same cross-sectional width as thecross-sectional width of the aperture in the base.

Statement 61: The apparatus according to any one of the precedingStatements 1-60, wherein the distal end and the proximal end of theinner bore have the same cross-sectional profile, wherein thecross-sectional profile is selected from the group consisting ofcircular, elliptical, and oval.

Statement 62: The apparatus according to any one of the precedingStatements 1-60, wherein the distal end and the proximal end of theinner bore have a different cross-sectional profile, wherein thecross-sectional profile is selected from the group consisting ofcircular, elliptical, and oval.

Statement 63: The apparatus according to Statement 62, wherein thedistal end and the proximal end of the inner bore have substantially thesame cross-sectional width.

Statement 64: An apparatus for inserting an implant into asurgically-created implant pocket in a subject, the apparatuscomprising: a base having an upper surface and a lower surface; and atubular member extending through the base, the tubular member having aninner bore, a proximal end and a distal end, the inner bore extendinglongitudinally a predetermined length away from the lower surface of thebase and between the proximal end and the distal end; and wherein thetubular member comprises a first aperture at the proximal end and asecond aperture at the distal end, wherein the inner bore is operable toreceive an implant at the first aperture and deliver the implanttherethrough at the second aperture, and wherein the inner bore has asubstantially uniform cross-sectional width over the predeterminedlength.

Statement 65: The apparatus according to Statement 64, wherein the baseradially extends from at least a portion of the proximal end of thetubular member.

Statement 66: The apparatus according to Statement 64 or Statement 65,wherein the inner bore has a longitudinal axis therethrough, the tubularmember extending along the longitudinal axis.

Statement 67: The apparatus according to any one of the precedingStatements 64-66, wherein the inner bore extends longitudinally along alongitudinal axis a predetermined length away from the lower surface ofthe base.

Statement 68: The apparatus according to Statement 66 or Statement 67,wherein the longitudinal axis extends substantially perpendicular to thebase.

Statement 69: The apparatus according to any one of the precedingStatements 64-68, wherein the tubular member extends longitudinallyalong a longitudinal axis substantially perpendicular to the base.

Statement 70: The apparatus according to any one of the precedingStatements 64-69, wherein the tubular member extends substantiallyorthogonally from the base.

Statement 71: The apparatus according to any one of the precedingStatements 64-70, wherein the base extends away from the tubular memberin a direction substantially perpendicular to the longitudinal axis.

Statement 72: The apparatus according to any one of the precedingStatements 64-71, wherein the tubular member is substantiallycylindrical in cross-sectional shape.

Statement 73: The apparatus according to any one of the precedingStatements 64-71, wherein the tubular member is elliptical incross-sectional shape.

Statement 74: The apparatus according to any one of the precedingStatements 64-73, wherein at least a portion of the inner bore oftubular member extends a second predetermined length above the uppersurface of the base.

Statement 75: The apparatus according to any one of the precedingStatements 64-74, wherein the lower surface of the base is operable toengage with a skin of the subject.

Statement 76: The apparatus according to any one of the precedingStatements 64-75, wherein the lower surface of the base is operable toengage a skin of the subject adjacent to an incision, wherein the innerbore of tubular member substantially overlies at least a portion of theincision.

Statement 77: The apparatus according to any one of the precedingStatements 64-76, wherein the lower surface of the base is operable toengage with a skin of the subject so as to resist movement of the basewith respect to the skin when engaged with the skin.

Statement 78: The apparatus according to any one of the precedingStatements 64-77, wherein the lower surface is operable to frictionallyengage the skin of a subject, wherein the frictional engagement resistsmovement of the base relative to the skin.

Statement 79: The apparatus according to any one of the precedingStatements 64-78, wherein the lower surface comprises a texturedsurface.

Statement 80: The apparatus according to any one of the precedingStatements 64-79, wherein the lower surface comprises a surface operableto frictionally engage the skin of a subject once wetted.

Statement 81: The apparatus according to any one of the precedingStatements 64-79, wherein a fluid is disposed on one of the lowersurface and/or the skin of the patient, the fluid operable to form africtional engagement between the lower surface and the skin.

Statement 82: The apparatus according to any one of the precedingStatements 64-79, wherein an adhesive is disposed on the lower surface.

Statement 83: The apparatus according to Statement 82, wherein the lowersurface further comprises a removable backing, the removable backingoperable to expose the adhesive.

Statement 84: The apparatus according to any one of the precedingStatements 64-83, wherein the predetermined length is determined basedon a distance between an incision in the skin of a patient and asurgically-created implant pocket formed below the skin.

Statement 85: The apparatus according to any one of the precedingStatements 64-84, wherein the predetermined length between the proximalend and the distal end extends the inner bore operably to deliver animplant subdermally through the first aperture, inner bore, and secondaperture into the surgically-created implant pocket when the lowersurface of base is adjacently engaged with the skin of a patient and thedistal end is received into at least a portion of the implant pocket.

Statement 86: The apparatus according to any one of the precedingStatements 64-85, wherein the proximal end of tubular member is operableto receive an implant therethrough.

Statement 87: The apparatus according to Statement 86, wherein thetubular member is further operable to deliver the implant subdermally tothe implant pocket through the predetermined length of inner bore of thetubular member.

Statement 88: The apparatus according to any one of the precedingStatements 64-87, wherein the distal end of tubular member is operableto be inserted into an incision in the skin of the subject, and thetubular member is operable to be extended the predetermined length suchthat the distal end is received into at least a portion of thesurgically-created implant pocket.

Statement 89: The apparatus according to Statement 88, wherein tubularmember extends along at least a portion of a dissection tunnel formedbetween the incision and the implant pocket.

Statement 90: The apparatus according to Statement 88 or Statement 89,wherein the tubular member is operable to deliver the implant to theimplant pocket through a dissection tunnel connecting the incision tothe implant pocket without the implant contacting the dissection tunnel.

Statement 91: The apparatus according to any one of the precedingStatements 64-90, wherein the tubular member comprises an inner surfaceand an outer surface, the inner surface defining the inner bore oftubular member.

Statement 92: The apparatus according to any one of the precedingStatements 64-91, wherein the tubular member and the base are formedfrom the same material.

Statement 93: The apparatus according to any one of the precedingStatements 64-92, wherein the tubular member and base are formed from aflexible material.

Statement 94: The apparatus according to Statement 93, wherein theflexible material is resistant to stretching.

Statement 95: The apparatus according to Statement 93, wherein theflexible material is capable of stretching.

Statement 96: The apparatus according to Statement 93, wherein theflexible material is operable to stretch when an implant is insertedand/or physically manipulated through the longitudinal length of theinner bore of the tubular member.

Statement 97: The apparatus according to any one of the precedingStatements 93-96, wherein the flexible material is selected from thegroup consisting of plastic-containing fabrics, polymers, plastics,mylar, vinyls, polyvinyl chloride, ethylene and alpha-olefin copolymers,silicone, solid silicone, silicone rubber, and any combination thereof.

Statement 98: The apparatus according to any one of the precedingStatements 64-97, wherein the tubular member and the base are integrallyformed.

Statement 99: The apparatus according to any one of the precedingStatements 64-98, wherein the inner bore of tubular member is nottapered along the predetermined length.

Statement 100: The apparatus according to any one of the precedingStatements 64-99, wherein the inner bore comprises a lubricant.

Statement 101: The apparatus according to any one of the precedingStatements 64-99, wherein the inner surface of the tubular membercomprises a lubricant.

Statement 102: The apparatus according to any one of the precedingStatements 64-99, wherein the outer surface of the tubular membercomprises a lubricant.

Statement 103: The apparatus according to any one of the precedingStatements 100-102, wherein the lubricant is a sterile lubricantselected from the group consisting of a surgical lubricant, awater-based lubricating jelly, a dry lubricant, a powdered lubricant, amoisture-activated lubricant, and any combination thereof.

Statement 104: The apparatus according to any one of the precedingStatements 64-103, wherein the inner bore comprises a lubricatingcoating or a friction-reducing coating.

Statement 105: The apparatus according to any one of the precedingStatements 64-103, wherein the inner surface of the tubular membercomprises a lubricating coating or a friction-reducing coating.

Statement 106: The apparatus according to any one of the precedingStatements 64-103, wherein the outer surface of the tubular membercomprises a lubricating coating or a friction-reducing coating.

Statement 107: The apparatus according to any one of the precedingStatements 64-106, wherein the predetermined length of the inner bore isequal to or less than a measured length of the dissection tunnel.

Statement 108: The apparatus according to any one of the precedingStatements 64-106, wherein the predetermined length of the inner bore isequal to or less than a measured length of the upper dissection tunnel.

Statement 109: The apparatus according to any one of the precedingStatements 64-108, wherein the predetermined length of the inner bore isgreater than 1 cm.

Statement 110: The apparatus according to any one of the precedingStatements 64-108, wherein the predetermined length of the inner bore isgreater than 1.5 cm.

Statement 111: The apparatus according to any one of the precedingStatements 64-108, wherein the predetermined length of the inner bore isgreater than 2 cm.

Statement 112: The apparatus according to any one of the precedingStatements 64-108, wherein the predetermined length of the inner bore isgreater than 2.5 cm.

Statement 113: The apparatus according to any one of the precedingStatements 64-108, wherein the predetermined length of the inner bore isgreater than 3 cm.

Statement 114: The apparatus according to any one of the precedingStatements 64-108, wherein the predetermined length of the inner bore isgreater than 3.5 cm.

Statement 115: The apparatus according to any one of the precedingStatements 64-108, wherein the predetermined length of the inner bore isgreater than 4 cm.

Statement 116: The apparatus according to any one of the precedingStatements 64-108, wherein the predetermined length of the inner bore isgreater than 4.5 cm.

Statement 117: The apparatus according to any one of the precedingStatements 64-108, wherein the predetermined length of the inner bore isgreater than 5 cm.

Statement 118: The apparatus according to any one of the precedingStatements 64-108, wherein the predetermined length of the inner bore isfrom about 1.5 cm to about 10 cm.

Statement 119: The apparatus according to any one of the precedingStatements 64-108, wherein the predetermined length of the inner bore isfrom about 1.5 cm to about 5 cm.

Statement 120: The apparatus according to any one of the precedingStatements 64-108, wherein the predetermined length of the inner bore isfrom about 3 cm to about 8 cm.

Statement 121: The apparatus according to any one of the precedingStatements 64-120, wherein the second aperture that is substantiallyaligned with the first aperture when the tubular member is fullyextended.

Statement 122: The apparatus according to any one of the precedingStatements 64-121, wherein the distal end has substantially the samecross-sectional width as the cross-sectional width of the proximal end.

Statement 123: The apparatus according to any one of the precedingStatements 64-122, wherein the cross-sectional width of the inner boreat the distal end of the tubular member is substantially the same as thecross-sectional width of the inner bore at the proximal end of thetubular member.

Statement 124: The apparatus according to any one of the precedingStatements 64-123, wherein the second aperture has substantially thesame cross-sectional width as the first aperture.

Statement 125: The apparatus according to any one of the precedingStatements 64-124, wherein the distal end and the proximal end of theinner bore have the same cross-sectional profile, wherein thecross-sectional profile is selected from the group consisting ofcircular, elliptical, and oval.

Statement 126: The apparatus according to any one of the precedingStatements 64-124, wherein the distal end and the proximal end of theinner bore have a different cross-sectional profile, wherein thecross-sectional profile is selected from the group consisting ofcircular, elliptical, and oval.

Statement 127: The apparatus according to Statement 126, wherein thedistal end and the proximal end of the inner bore have substantially thesame cross-sectional width.

Statement 128: The apparatus according to any one of the precedingStatements 64-124, wherein the first aperture and the second aperturehave the same cross-sectional profile, wherein the cross-sectionalprofile is selected from the group consisting of circular, elliptical,and oval.

Statement 129: The apparatus according to any one of the precedingStatements 64-124, wherein the first aperture and the second aperturehave a different cross-sectional profile, wherein the cross-sectionalprofile is selected from the group consisting of circular, elliptical,and oval.

Statement 130: The apparatus according to Statement 129, wherein thefirst aperture and the second aperture have substantially the samecross-sectional width.

Statement 131: A system comprising: an apparatus for inserting animplant into a surgically-created implant pocket in a subject accordingto any one of the preceding Statements 1-130, 245-274, and 283; and animplant.

Statement 132: A system comprising: an apparatus for inserting animplant into a surgically-created implant pocket in a subject accordingto any one of Statements 1-130, 245-274, and 283; and a conical sleevehaving a an interior cavity, a first terminus, and a second terminus,wherein the first terminus has a larger diameter than the secondterminus; wherein the second terminus is operable to be inserted intothe aperture or inner bore of the tubular member of the apparatus, theconical sleeve further operable to receive an implant into its interiorcavity via the first terminus and deliver the implant through the secondterminus into the inner bore of the apparatus.

Statement 133: The system according to Statement 132, further comprisingan implant.

Statement 134: A kit comprising: an apparatus for inserting an implantinto a surgically-created implant pocket in a subject according to anyone of Statements 1-130, 245-274, and 283; and an implant; wherein theapparatus and the implant are packaged together.

Statement 135: A kit comprising: an apparatus for inserting an implantinto a surgically-created implant pocket in a subject according to anyone of Statements 1-130, 245-274, and 283; and a conical sleeve having aan interior cavity, a first terminus, and a second terminus, wherein thefirst terminus has a larger diameter than the second terminus; whereinthe second terminus is operable to be inserted into the aperture orinner bore of the tubular member of the apparatus, the conical sleevefurther operable to receive an implant into its interior cavity via thefirst terminus and deliver the implant through the second terminus intothe inner bore of the apparatus; wherein the apparatus and the implantare packaged together.

Statement 136: The kit according to Statement 135, further comprising animplant.

Statement 137: The apparatus according to any one of Statements 1-130,245-274, and 283, wherein the implant is selected from the groupconsisting of a filled implant or a pre-filled implant, an unfilledimplant, a saline implant, a silicone gel implant, a textured implant, asmooth implant, a highly cohesive silicone gel implant, an oil-filledimplant, a pacemaker, a joint replacement prosthesis, an allograft, anautograft, and a prosthesis implant.

Statement 138: The system according to any one of the precedingStatements 131-133, wherein the implant is selected from the groupconsisting of a filled implant or a pre-filled implant, an unfilledimplant, a saline implant, a silicone gel implant, a textured implant, asmooth implant, a highly cohesive silicone gel implant, an oil-filledimplant, a pacemaker, a joint replacement prosthesis, an allograft, anautograft, and a prosthesis implant.

Statement 139: The kit according to any one of the preceding Statements134-136, wherein the implant is selected from the group consisting of afilled implant or a pre-filled implant, an unfilled implant, a salineimplant, a silicone gel implant, a textured implant, a smooth implant, ahighly cohesive silicone gel implant, an oil-filled implant, apacemaker, a joint replacement prosthesis, an allograft, an autograft,and a prosthesis implant.

Statement 140: A method for inserting an implant into asurgically-created implant pocket in a subject through a dissectiontunnel connecting the implant pocket to an incision on the skin of thesubject, the method comprising: providing a sterile biofilm protectionimplant shield, the implant shield comprising: a base having an uppersurface and a lower surface, the base further having an aperture formedtherein and extending through the upper surface and the lower surface;and a tubular member coupled with the base, the tubular member having aninner bore extending longitudinally between a proximal end and a distalend, the inner bore extending a predetermined length away from the lowersurface of the base; wherein the proximal end of the tubular member iscoupled with the base and the inner bore is substantially aligned withthe aperture formed in the base; and wherein the inner bore is operableto receive the implant therethrough and has a substantially uniformcross-sectional width over the predetermined length; inserting thedistal end of the tubular member of the implant shield through theincision in the skin of subject and into the dissection tunnel such thatthe distal end of the tubular member is received in at least a portionof the dissection tunnel or the implant pocket; causing the lowersurface of the base to substantially engage with at least a portion ofthe skin adjacent to an incision leading to the implant pocket; anddelivering the implant to the implant pocket by inserting the implantthrough the aperture of the base and through the inner bore and distalend of the tubular member to the implant pocket.

Statement 141: The method according to Statement 140, furthercomprising: opening the dissection tunnel using one or more retractorsduring inserting the tubular member of the implant shield into theimplant pocket or a portion of a dissection tunnel.

Statement 142: The method according to Statement 140 or Statement 141,wherein inserting the tubular member of the implant shield into theimplant pocket or a portion of a dissection tunnel connecting theimplant pocket to an incision on a skin of the subject comprisesinserting the tubular member or a distal end thereof using forceps or asimilar device.

Statement 143: The method according to any one of the precedingStatements 140-142, further comprising: causing the lower surface of thebase to engage the skin of the subject so as to resist movement of thebase with respect to the skin when engaged with the skin.

Statement 144: The method according to Statement 143, wherein the baseis frictionally engaged with the skin of the subject.

Statement 145: The method according to Statement 143 or Statement 144,further comprising wetting the lower surface of the base to cause theengagement with the skin of the subject.

Statement 146: The method according to Statement 143, wherein the baseis engaged with the skin of the subject by an adhesive disposed on thelower surface of the base.

Statement 147: The method according to Statement 146, furthercomprising: exposing the adhesive disposed on the lower surface of thebase by removing a removable backing disposed on the lower surface ofthe base.

Statement 148: The method according to any one of the precedingStatements 140-148, further comprising: attaching the lower surface ofthe base to the skin of the subject so as to arrest movement of the basewith respect to the skin during use.

Statement 149: The method according to any one of the precedingStatements 143-148, wherein the aperture substantially overlies at leasta portion of the incision.

Statement 150: The method according to any one of the precedingStatements 140-149, further comprising: inserting the tubular member ofthe implant shield into the implant pocket or a portion of a dissectiontunnel connecting the implant pocket to an incision on a skin of thesubject, such that the lower surface of the base substantially engageswith at least a portion of the skin adjacent to the incision; andextending the tubular member of the implant shield through the fulllength of the dissection tunnel such that the distal end extends atleast partially into the implant pocket.

Statement 151: The method according to Statement 150, wherein thetubular member of the implant shield is extended through the dissectiontunnel using one or more retractors inserted through the aperture andinto the inner bore of the tubular member.

Statement 152: The method according to Statement 150, wherein thetubular member of the implant shield is extended through the dissectiontunnel using one or more retractors placed outside the aperture andbetween the tubular member and a tissue forming the dissection tunnel.

Statement 153: The method according to any one of the precedingStatements 150-152, wherein prior to delivering the implant to theimplant pocket, the method further comprises: inserting one or moreretractors through the aperture and into the inner bore of the tubularmember so as to open the inner bore and dissection tunnel for implantinsertion.

Statement 154: The method according to any one of the precedingStatements 140-153, wherein the implant is delivered to the implantpocket such that the entire tissue path between an incision on thesubject's skin and the implant pocket is shielded from the tissueforming a dissection tunnel connecting the incision to the implantpocket.

Statement 155: The method according to any one of the precedingStatements 140-154, wherein the implant does not contact the tissueforming the dissection tunnel during delivery to the implant pocket.

Statement 156: The method according to any one of the precedingStatements 140-154, wherein the implant shield substantially minimizesthe contact of the implant with the tissue forming the dissectiontunnel.

Statement 157: The method according to any one of the precedingStatements 140-156, wherein the inner bore of the tubular member forms asterile path by which the implant may be inserted and delivered to theimplant pocket.

Statement 158: The method according to any one of the precedingStatements 140-157, wherein the inner bore of the tubular member forms asterile path, through which the implant may be delivered, from anincision in a skin of the patient to the implant pocket through adissection tunnel connecting the incision to the implant pocket.

Statement 159: The method according to any one of the precedingStatements 140-158, further comprising: causing the lower surface of thebase to disengage from the skin of subject; and removing the tubularmember and implant shield from the subject.

Statement 160: The method according to any one of the precedingStatements 140-159, further comprising: closing the incision.

Statement 161: The method according to any one of the precedingStatements 140-160, further comprising: selecting a biofilm protectionimplant shield having an inner bore with a cross-sectional width greatthan the diameter of the implant.

Statement 162: The method according to any one of the precedingStatements 140-161, further comprising: sterilizing the biofilmprotection implant shield.

Statement 163: The method according to any one of the precedingStatements 140-162, further comprising: selecting a biofilm protectionimplant shield having a predetermined length of the inner bore of thetubular member sufficiently long that the tubular member is operable toshield the implant from the upper dissection tunnel and/or a substantiallength of the dissection tunnel upon insertion of the implant into theinner bore of the tubular member and transit of the implant to theimplant pocket in a subject.

Statement 164: The method according to Statement 163, wherein thesubstantial length of the dissection tunnel corresponds to at least theentire portion of the dissection tunnel that comprises breast tissue.

Statement 165: The method according to any one of the precedingStatements 140-162, further comprising: selecting a biofilm protectionimplant shield having a predetermined length of the inner bore of thetubular member equal to or less than a length of a dissection tunnelconnecting the implant pocket to an incision on a skin of the subject.

Statement 166: The method according to any one of the precedingStatements 140-162, further comprising: selecting a biofilm protectionimplant shield having a predetermined length of the inner bore of thetubular member equal to or greater than a length of a dissection tunnelconnecting the implant pocket to an incision on a skin of the subject.

Statement 167: The method according to any one of the precedingStatements 140-162, further comprising: measuring a length of adissection tunnel and/or upper dissection tunnel connecting the implantpocket to an incision on a skin of the subject; and adjusting thepredetermined length of the inner bore of the tubular member such thatit has a length equal to or less than the length of the dissectiontunnel or upper dissection tunnel.

Statement 168: The method according to Statement 167, wherein adjustingthe predetermined length comprises cutting the tubular member such thatthe predetermined length of the inner bore of the tubular member has alength equal to or less than the length of the dissection tunnel orupper dissection tunnel.

Statement 169: The method according to any one of the precedingStatements 140-162, further comprising: measuring a length of adissection tunnel or upper dissection tunnel connecting the implantpocket to an incision on a skin of the subject; and adjusting thepredetermined length of the inner bore of the tubular member such thatit has a length equal to or greater than the length of the dissectiontunnel or upper dissection tunnel.

Statement 170: The method according to Statement 169, wherein adjustingthe predetermined length comprises cutting the tubular member such thatthe predetermined length of the inner bore of the tubular member has alength equal to or greater than the length of the dissection tunnel orupper dissection tunnel.

Statement 171: The method according to any one of the precedingStatements 140-170, further comprising: creating an incision in the skinof the subject; and surgically-creating an implant pocket and adissection tunnel connecting the incision to the surgically-createdimplant pocket.

Statement 172: The method according to any one of the precedingStatements 140-171, wherein delivering the implant to the implant pocketcomprises: providing a conical sleeve having a an interior cavity, afirst terminus, and a second terminus, wherein the first terminus has alarger diameter than the second terminus; placing the implant into theinterior cavity of the conical sleeve; inserting the second terminusthrough the aperture of the base and into the inner bore of the tubularmember such that the terminus of the conical sleeve is received in theimplant shield proximal to the implant pocket; and applying pressure tothe conical sleeve such that the implant exits the second terminus ofthe conical sleeve and is delivered to the implant pocket.

Statement 173: The method according to Statement 172, wherein theconical sleeve is a tapered sleeve.

Statement 174: The method according to any one of the precedingStatements 140-173, wherein the subject is a mammal.

Statement 175: The method according to any one of the precedingStatements 140-173, wherein the subject is a human.

Statement 176: The method according to any one of the precedingStatements 140-175, wherein the implant is selected from the groupconsisting of a breast implant, a pre-filled implant, a pre-filledsaline breast implant, a pre-filled silicone breast implant, anun-filled breast implant, a saline breast implant, a silicone breastimplant, a textured breast implant, a smooth breast implant, a highlycohesive silicone gel breast implant, an oil-filled breast implant, andan un-filled saline breast implant.

Statement 177: The method according to any one of the precedingStatements 140-176, wherein the incision is a periareolar incision.

Statement 178: The method according to any one of the precedingStatements 140-176, wherein the incision is an inframammary incision.

Statement 179: The method according to any one of the precedingStatements 140-176, wherein the incision is an axillary incision.

Statement 180: The method according to any one of the precedingStatements 140-176, wherein the incision is a transumbilical incision.

Statement 181: The method according to any one of the precedingStatements 140-176, wherein the incision is a vertical incision.

Statement 182: A method of preventing capsular contracture in a subjectresulting from surgical insertion of a breast implant in a surgicallycreated implant pocket through a dissection tunnel connecting theimplant pocket to an incision on the skin of the patient, the methodcomprising: providing a sterile biofilm protection implant shield, theimplant shield comprising: a base having an upper surface and a lowersurface, the base further having an aperture formed therein andextending through the upper surface and the lower surface; and a tubularmember coupled with the base, the tubular member having an inner boreextending longitudinally between a proximal end and a distal end, theinner bore extending a predetermined length away from the lower surfaceof the base; wherein the proximal end of the tubular member is coupledwith the base and the inner bore is substantially aligned with theaperture formed in the base; and wherein the inner bore is operable toreceive the implant therethrough and has a substantially uniformcross-sectional width over the predetermined length; inserting thedistal end of the tubular member of the implant shield through theincision in the skin of subject and into the dissection tunnel such thatthe distal end of the tubular member is received in at least a portionof the dissection tunnel or the implant pocket; causing the lowersurface of the base to substantially engage with at least a portion ofthe skin adjacent to an incision leading to the implant pocket; anddelivering the implant to the implant pocket by inserting the implantthrough the aperture of the base and through the inner bore and distalend of the tubular member to the implant pocket.

Statement 183: The method according to Statement 182, furthercomprising: opening the dissection tunnel using one or more retractorsduring inserting the tubular member of the implant shield into theimplant pocket or a portion of a dissection tunnel.

Statement 184: The method according to Statement 182, wherein insertingthe tubular member of the implant shield into the implant pocket or aportion of a dissection tunnel connecting the implant pocket to anincision on a skin of the subject comprises inserting the tubular memberor a distal end thereof using forceps or a similar device.

Statement 185: The method according to Statement 182, furthercomprising: causing the lower surface of the base to engage the skin ofthe subject so as to resist movement of the base with respect to theskin when engaged with the skin.

Statement 186: The method according to Statement 185, wherein the baseis frictionally engaged with the skin of the subject.

Statement 187: The method according to Statement 185, wherein the baseis engaged with the skin of the subject by an adhesive disposed on thelower surface of the base.

Statement 188: The method according to Statement 187, furthercomprising: exposing the adhesive disposed on the lower surface of thebase by removing a removable backing disposed on the lower surface ofthe base.

Statement 189: The method according to any one of the precedingStatements 182-188, further comprising: attaching the lower surface ofthe base to the skin of the subject so as to arrest movement of the basewith respect to the skin during use.

Statement 190: The method according to any one of the precedingStatements 182-189, wherein the aperture substantially overlies at leasta portion of the incision.

Statement 191: The method according to any one of the precedingStatements 182-190, further comprising: inserting the tubular member ofthe implant shield into the implant pocket or a portion of a dissectiontunnel connecting the implant pocket to an incision on a skin of thesubject, such that the lower surface of the base substantially engageswith at least a portion of the skin adjacent to the incision; andextending the tubular member of the implant shield through the fulllength of the dissection tunnel such that the distal end extends atleast partially into the implant pocket.

Statement 192: The method according to Statement 191, wherein thetubular member of the implant shield is extended through the dissectiontunnel using one or more retractors inserted through the aperture andinto the inner bore of the tubular member.

Statement 193: The method according to Statement 191, wherein thetubular member of the implant shield is extended through the dissectiontunnel using one or more retractors placed outside the aperture andbetween the tubular member and a tissue forming the dissection tunnel.

Statement 194: The method according to any one of the precedingStatements 191-193, wherein prior to delivering the implant to theimplant pocket, the method further comprises: inserting one or moreretractors through the aperture and into the inner bore of the tubularmember so as to open the inner bore and dissection tunnel for implantinsertion.

Statement 195: The method according to any one of the precedingStatements 182-194, wherein the implant is delivered to the implantpocket such that the entire tissue path between an incision on thesubject's skin and the implant pocket is shielded from the tissueforming a dissection tunnel connecting the incision to the implantpocket.

Statement 196: The method according to any one of the precedingStatements 182-195, wherein the implant does not contact the tissueforming the dissection tunnel during delivery to the implant pocket.

Statement 197: The method according to any one of the precedingStatements 182-195, wherein the implant shield substantially minimizesthe contact of the implant with the tissue forming the dissectiontunnel.

Statement 198: The method according to any one of the precedingStatements 182-197, wherein the inner bore of the tubular member forms asterile path by which the implant may be inserted and delivered to theimplant pocket.

Statement 199: The method according to any one of the precedingStatements 182-198, wherein the inner bore of the tubular member forms asterile path, through which the implant may be delivered, from anincision in a skin of the patient to the implant pocket through adissection tunnel connecting the incision to the implant pocket.

Statement 200: The method according to any one of the precedingStatements 182-199, further comprising: causing the lower surface of thebase to disengage from the skin of subject; and removing the tubularmember and implant shield from the subject.

Statement 201: The method according to any one of the precedingStatements 182-200, further comprising: closing the incision.

Statement 202: The method according to any one of the precedingStatements 182-201, further comprising: selecting a biofilm protectionimplant shield having an inner bore with a cross-sectional width greatthan the diameter of the implant.

Statement 203: The method according to any one of the precedingStatements 182-202, further comprising: sterilizing the biofilmprotection implant shield.

Statement 204: The method according to any one of the precedingStatements 182-202, further comprising: selecting a biofilm protectionimplant shield having a predetermined length of the inner bore of thetubular member sufficiently long that the tubular member is operable toshield the implant from the upper dissection tunnel and/or a substantiallength of the dissection tunnel upon insertion of the implant into theinner bore of the tubular member and transit of the implant to theimplant pocket in a subject.

Statement 205: The method according to Statement 204, wherein thesubstantial length of the dissection tunnel corresponds to at least theentire portion of the dissection tunnel that comprises breast tissue.

Statement 206: The method according to any one of the precedingStatements 182-203, further comprising: selecting a biofilm protectionimplant shield having a predetermined length of the inner bore of thetubular member equal to or less than a length of a dissection tunnel oran upper dissection tunnel connecting the implant pocket to an incisionon a skin of the subject.

Statement 207: The method according to any one of the precedingStatements 182-203, further comprising: selecting a biofilm protectionimplant shield having a predetermined length of the inner bore of thetubular member equal to or greater than a length of a dissection tunnelor an upper dissection tunnel connecting the implant pocket to anincision on a skin of the subject.

Statement 208: The method according to any one of the precedingStatements 182-203, further comprising: measuring a length of adissection tunnel or upper dissection tunnel connecting the implantpocket to an incision on a skin of the subject; and adjusting thepredetermined length of the inner bore of the tubular member such thatit has a length equal to or less than the length of the dissectiontunnel or upper dissection tunnel.

Statement 209: The method according to Statement 208, wherein adjustingthe predetermined length comprises cutting the tubular member such thatthe predetermined length of the inner bore of the tubular member has alength equal to or less than the length of the dissection tunnel orupper dissection tunnel.

Statement 210: The method according to any one of the precedingStatements 182-203, further comprising: measuring a length of adissection tunnel or upper dissection tunnel connecting the implantpocket to an incision on a skin of the subject; and adjusting thepredetermined length of the inner bore of the tubular member such thatit has a length equal to or greater than the length of the dissectiontunnel or upper dissection tunnel.

Statement 211: The method according to Statement 210, wherein adjustingthe predetermined length comprises cutting the tubular member such thatthe predetermined length of the inner bore of the tubular member has alength equal to or greater than the length of the dissection tunnel orupper dissection tunnel.

Statement 212: The method according to any one of the precedingStatements 182-211, further comprising: creating an incision in the skinof the subject; and surgically-creating an implant pocket and adissection tunnel connecting the incision to the surgically-createdimplant pocket.

Statement 213: The method according to any one of the precedingStatements 182-212, wherein delivering the implant to the implant pocketcomprises: providing a conical sleeve having a an interior cavity, afirst terminus, and a second terminus, wherein the first terminus has alarger diameter than the second terminus; placing the implant into theinterior cavity of the conical sleeve; inserting the second terminusthrough the aperture of the base and into the inner bore of the tubularmember such that the terminus of the conical sleeve is received in theimplant shield proximal to the implant pocket; and applying pressure tothe conical sleeve such that the implant exits the second terminus ofthe conical sleeve and is delivered to the implant pocket.

Statement 214: The method according to Statement 213, wherein theconical sleeve is a tapered sleeve.

Statement 215: The method according to any one of the precedingStatements 182-214, wherein the subject is a mammal.

Statement 216: The method according to any one of the precedingStatements 182-214, wherein the subject is a human.

Statement 217: The method according to any one of the precedingStatements 182-216, wherein the implant is selected from the groupconsisting of a breast implant, a pre-filled breast implant, apre-filled saline breast implant, a pre-filled silicone breast implant,an un-filled breast implant, a saline breast implant, a silicone breastimplant, a textured breast implant, a smooth breast implant, a highlycohesive silicone gel breast implant, an oil-filled breast implant, andan un-filled saline breast implant.

Statement 218: The method according to any one of the precedingStatements 182-217, wherein the incision is a periareolar incision.

Statement 219: The method according to any one of the precedingStatements 182-217, wherein the incision is an inframammary incision.

Statement 220: The method according to any one of the precedingStatements 182-217, wherein the incision is an axillary incision.

Statement 221: The method according to any one of the precedingStatements 182-217, wherein the incision is a transumbilical incision.

Statement 222: The method according to any one of the precedingStatements 182-217, wherein the incision is a vertical incision.

Statement 223: The method according to any one of the precedingStatements 140-222, wherein the implant is selected from the groupconsisting of a filled implant or a pre-filled implant, an unfilledimplant, a saline implant, a silicone gel implant, a textured implant, asmooth implant, a highly cohesive silicone gel implant, an oil-filledimplant, a pacemaker, a joint replacement prosthesis, an allograft, anautograft, and a prosthesis implant.

Statement 224: The method according to any one of the precedingStatements 140-223, wherein the implant is an unfilled implant and theimplant has a cross-sectional width smaller than the cross-sectionalwidth of the tubular member of the implant shield.

Statement 225: The method according to any one of the precedingStatements 140-223, wherein the implant has a cross-sectional widthsmaller than the cross-sectional width of the tubular member of theimplant shield due to the deformation forces during insertion of theimplant into the aperture and inner bore of the implant shield.

Statement 226: The method according to any one of the precedingStatements 140-225, wherein the distal end of the tubular member isinserted greater than 1.5 cm below the incision.

Statement 227: The method according to any one of the precedingStatements 140-225, wherein the distal end of the tubular member isinserted greater than 2 cm below the incision.

Statement 228: The method according to any one of the precedingStatements 140-225, wherein the distal end of the tubular member isinserted greater than 2.5 cm below the incision.

Statement 229: The method according to any one of the precedingStatements 140-225, wherein the distal end of the tubular member isinserted greater than 3 cm below the incision.

Statement 230: The method according to any one of the precedingStatements 140-225, wherein the distal end of the tubular member isinserted greater than 3.5 cm below the incision.

Statement 231: The method according to any one of the precedingStatements 140-225, wherein the distal end of the tubular member isinserted greater than 4.5 cm below the incision.

Statement 232: The method according to any one of the precedingStatements 140-225, wherein the distal end of the tubular member isinserted greater than 5 cm below the incision.

Statement 233: The method according to any one of the precedingStatements 140-225, wherein the distal end of the tubular member isinserted into the dissection tunnel to a depth of from about 2 cm toabout 10 cm below the incision.

Statement 234: The method according to any one of the precedingStatements 140-225, wherein the distal end of the tubular member isinserted into the dissection tunnel to a depth of from about 2 cm toabout 5 cm below the incision.

Statement 235: The method according to any one of the precedingStatements 140-225, wherein the distal end of the tubular member isinserted into the dissection tunnel to a depth of from about 3 cm toabout 8 cm below the incision.

Statement 236: The method according to any one of the precedingStatements 140-225, wherein the distal end of the tubular member isinserted such that at least 1.5 cm of the length of the dissectiontunnel is shielded from the implant during insertion of the implant intothe implant pocket.

Statement 237: The method according to any one of the precedingStatements 140-225, wherein the distal end of the tubular member isinserted such that at least 2 cm of the length of the dissection tunnelis shielded from the implant during insertion of the implant into theimplant pocket.

Statement 238: The method according to any one of the precedingStatements 140-225, wherein the distal end of the tubular member isinserted such that at least 2.5 cm of the length of the dissectiontunnel is shielded from the implant during insertion of the implant intothe implant pocket.

Statement 239: The method according to any one of the precedingStatements 140-225, wherein the distal end of the tubular member isinserted such that at least 3 cm of the length of the dissection tunnelis shielded from the implant during insertion of the implant into theimplant pocket.

Statement 240: The method according to any one of the precedingStatements 140-225, wherein the distal end of the tubular member isinserted such that at least 3.5 cm of the length of the dissectiontunnel is shielded from the implant during insertion of the implant intothe implant pocket.

Statement 241: The method according to any one of the precedingStatements 140-225, wherein the distal end of the tubular member isinserted such that at least 4 cm of the length of the dissection tunnelis shielded from the implant during insertion of the implant into theimplant pocket.

Statement 242: The method according to any one of the precedingStatements 140-225, wherein the distal end of the tubular member isinserted such that at least 4.5 cm of the length of the dissectiontunnel is shielded from the implant during insertion of the implant intothe implant pocket.

Statement 243: The method according to any one of the precedingStatements 140-225, wherein the distal end of the tubular member isinserted such that at least 5 cm of the length of the dissection tunnelis shielded from the implant during insertion of the implant into theimplant pocket.

Statement 244: The method according to any one of the precedingStatements 140-225, wherein the distal end of the tubular member isinserted into the dissection tunnel such that the entire upperdissection tunnel is shielded from the implant during insertion of theimplant into the implant pocket.

Statement 245: The apparatus according to any one of the precedingStatements 1-130, wherein the base extends away from the tubular memberin substantially the same plane as the aperture of the base.

Statement 246: The apparatus according to any one of the precedingStatements 1-130 and 245, wherein the cross-sectional width of the innerbore of the tubular member is from about 3 cm to about 12 cm.

Statement 247: The apparatus according to any one of the precedingStatements 1-130 and 245, wherein the cross-sectional width of the innerbore of the tubular member is from about 5 cm to about 8 cm.

Statement 248: The apparatus according to any one of the precedingStatements 1-130 and 245, wherein the cross-sectional width of the innerbore of the tubular member is from about 3.5 cm to about 9 cm.

Statement 249: The apparatus according to any one of the precedingStatements 1-130 and 245-248, wherein the base comprises a diameter thatis at least three times greater than the cross-sectional width of theinner bore of the tubular member.

Statement 250: The apparatus according to any one of the precedingStatements 1-130 and 245-248, wherein the base comprises a diameter thatis at least three times greater than the cross-sectional width of theaperture of the base.

Statement 251: The apparatus according to any one of the precedingStatements 1-130 and 245-248, wherein the base comprises a diameter thatis at least three times greater than the cross-sectional width of theouter bore of the tubular member.

Statement 252: The apparatus according to any one of the precedingStatements 1-130 and 245-248, wherein the base comprises a diameter thatis from about three (3) to five (5) times greater than thecross-sectional width of the inner bore of the tubular member.

Statement 253: The apparatus according to any one of the precedingStatements 1-130 and 245-248, wherein the base comprises a diameter thatis from about three (3) to five (5) times greater than thecross-sectional width of the aperture of the base.

Statement 254: The apparatus according to any one of the precedingStatements 1-130 and 245-248, wherein the base comprises a diameter thatis from about three (3) to five (5) times greater than thecross-sectional width of the outer bore of the tubular member.

Statement 255: The apparatus according to any one of the precedingStatements 1-130 and 245-248, wherein the base comprises a diameter thatis from about 9 cm to about 60 cm.

Statement 256: The apparatus according to any one of the precedingStatements 1-130 and 245-248, wherein the base comprises a diameter thatis from about 10.5 cm to about 45 cm.

Statement 257: The apparatus according to any one of the precedingStatements 1-130 and 245-248, wherein the base comprises a diameter thatis from about 15 cm to about 40 cm.

Statement 258: The apparatus according to any one of the precedingStatements 1-130 and 245-248, wherein the base comprises a radial lengththat is greater than or equal to the cross-sectional width of the innerbore of the tubular member.

Statement 259: The apparatus according to any one of the precedingStatements 1-130 and 245-248, wherein the base comprises a radial lengththat is greater than or equal to the cross-sectional width of theaperture of the base.

Statement 260: The apparatus according to any one of the precedingStatements 1-130 and 245-248, wherein the base comprises a radial lengththat is greater than or equal to the cross-sectional width of the outerbore of the tubular member.

Statement 261: The apparatus according to any one of the precedingStatements 1-130 and 245-248, wherein the base comprises a radial lengththat from about one (1) to about two (2) times cross-sectional width ofthe inner bore of the tubular member.

Statement 262: The apparatus according to any one of the precedingStatements 1-130 and 245-248, wherein the base comprises a radial lengththat from about one (1) to about two (2) times the cross-sectional widthof the aperture of the base.

Statement 263: The apparatus according to any one of the precedingStatements 1-130 and 245-248, wherein the base comprises a radial lengththat from about one (1) to about two (2) times the cross-sectional widthof the outer bore of the tubular member.

Statement 264: The apparatus according to any one of the precedingStatements 1-130 and 245-248, wherein the base comprises a radial lengthfrom about 3 cm to about 12 cm.

Statement 265: The apparatus according to any one of the precedingStatements 1-130 and 245-248, wherein the base comprises a radial lengthfrom about 3 cm to about 18 cm.

Statement 266: The apparatus according to any one of the precedingStatements 1-130 and 245-248, wherein the base comprises a radial lengthfrom about 5 cm to about 8 cm.

Statement 267: The apparatus according to any one of the precedingStatements 1-130 and 245-248, wherein the base comprises a radial lengthfrom about 10 cm to about 16 cm.

Statement 268: The apparatus according to any one of the precedingStatements 1-130 and 245-248, wherein the base comprises a radial lengthfrom about 5 cm to about 16 cm.

Statement 269: The apparatus according to any one of the precedingStatements 1-130 and 245-268, wherein the tubular member is stretchable.

Statement 270: The apparatus according to any one of the precedingStatements 1-130 and 245-268, wherein the tubular member comprises astretchable material.

Statement 271: The apparatus according to any one of the precedingStatements 1-130 and 245-268, wherein the tubular member is elastic.

Statement 272: The apparatus according to any one of the precedingStatements 1-130 and 245-268, wherein the tubular member comprises anelastic material.

Statement 273: The apparatus according to any one of the precedingStatements 1-130 and 245-268, wherein the tubular member is extensible.

Statement 274: The apparatus according to any one of the precedingStatements 1-130 and 245-268, wherein the tubular member comprises anextensible material.

Statement 275: The method according to any one of the precedingStatements 140-244, wherein the tubular member is operable to stretchduring insertion of the implant into the inner bore of the tubularmember.

Statement 276: The method according to any one of the precedingStatements 140-244, wherein the tubular member is stretchable.

Statement 277: The method according to any one of the precedingStatements 140-244, wherein the tubular member comprises a stretchablematerial.

Statement 278: The method according to any one of the precedingStatements 140-244, wherein the tubular member is elastic.

Statement 279: The method according to any one of the precedingStatements 140-244, wherein the tubular member comprises an elasticmaterial.

Statement 280: The method according to any one of the precedingStatements 140-244, wherein the tubular member is extensible.

Statement 281: The method according to any one of the precedingStatements 140-244, wherein the tubular member comprises an extensiblematerial.

Statement 282: The method according to any one of the precedingStatements 140-244 and 275-281, wherein the aperture of the base has across-sectional width that is substantially the same as thecross-sectional width of the inner bore of the tubular member.

Statement 283: The apparatus according to any one of the precedingStatements 1-130 and 245-274, wherein the aperture of the base has across-sectional width that is substantially the same as thecross-sectional width of the inner bore of the tubular member.

What is claimed is:
 1. An apparatus for inserting a breast implant intoa surgically-created implant pocket in a breast of a subject, theapparatus comprising: a base having an upper surface and a lowersurface, the base having an aperture formed therein and extendingthrough the upper surface and the lower surface, wherein the aperture isoperable to receive the breast implant therethrough; and a tubularmember coupled with the base, the tubular member having an inner boreextending longitudinally between a proximal end having a proximalopening and a distal end having a distal opening, the inner boreextending a predetermined length away from the lower surface of thebase; wherein the proximal end of the tubular member is coupled with thelower surface of the base and the distal end of the tubular memberextends a predetermined length away from the lower surface of the base;wherein the inner bore of the tubular member is substantially alignedwith the aperture formed in the base; wherein the inner bore is operableto receive the breast implant therethrough and has a substantiallyuniform cross-sectional width over the predetermined length; wherein theupper surface of the base forms the proximal most end of the apparatusand the distal end of the tubular member forms the distal most end ofthe apparatus; and wherein the base comprises a diameter that is atleast three times greater than the cross-sectional width of the innerbore of the tubular member.
 2. The apparatus according to claim 1,wherein the lower surface of the base is operable to frictionally engagethe skin of a subject, wherein the frictional engagement resistsmovement of the base relative to the skin.
 3. The apparatus according toclaim 2, wherein the lower surface comprises a surface operable tofrictionally engage the skin of a subject once wetted.
 4. The apparatusaccording to claim 1, wherein an adhesive is disposed on the lowersurface of the base.
 5. The apparatus according to claim 4, wherein thelower surface further comprises a removable backing, the removablebacking operable to expose the adhesive.
 6. The apparatus according toclaim 1, wherein the predetermined length is determined based on adistance between an incision in the skin of a patient and asurgically-created implant pocket formed below the skin.
 7. Theapparatus according to claim 1, wherein the tubular member comprises aninner surface and an outer surface, the inner surface comprising alubricant and defining the inner bore of tubular member.
 8. Theapparatus according to claim 1, wherein the predetermined length isgreater than 1 cm.
 9. The apparatus according to claim 1, wherein thepredetermined length is from about 2 cm to about 10 cm.
 10. Theapparatus according to claim 1, wherein the base extends away from thetubular member in substantially the same plane as the aperture of thebase.
 11. The apparatus according to claim 1, wherein the base comprisesa diameter that is from about three (3) to five (5) times greater thanthe cross-sectional width of the inner bore of the tubular member. 12.The apparatus according to claim 1, wherein the tubular member isstretchable.
 13. The apparatus according to claim 1, wherein the baseand the tubular member are formed from a flexible material, the flexiblematerial selected from the group consisting of plastic-containingfabrics, polymers, plastics, polyethylene terephthalate, vinyls,polyvinyl chloride, ethylene and alpha-olefin copolymers, silicone,solid silicone, silicone rubber, and any combination thereof.
 14. Theapparatus according to claim 1, wherein the lower surface of the base isoperable to removably engage the skin of the subject so as tosubstantially resist movement of the base relative to the skin of thesubject during implant insertion into the aperture and inner bore. 15.An apparatus for shielding an implant from a dissection tunnel in asubject during insertion of the implant into a surgically-createdimplant pocket connected to an incision in the skin of the subject bythe dissection tunnel, the apparatus comprising: a base having an uppersurface and a lower surface, the base having an aperture formed thereinand extending through the upper surface and the lower surface, whereinthe aperture is operable to receive the implant therethrough; and atubular member coupled with the base, the tubular member having an innerbore extending longitudinally between a proximal end having a proximalopening and a distal end having a distal opening, the inner boreextending a predetermined length away from the lower surface of thebase; wherein the proximal end of the tubular member is coupled with thelower surface of the base and the distal end of the tubular memberextends a predetermined length away from the lower surface of the base,the distal end of the tubular member operable to be inserted into thedissection tunnel in the subject connecting the incision in the skin ofthe subject to the surgically-created implant pocket; wherein the innerbore of the tubular member is substantially aligned with the apertureformed in the base; wherein the inner bore is operable to receive theimplant therethrough and has a substantially uniform cross-sectionalwidth over the predetermined length; wherein the upper surface of thebase forms the proximal most end of the apparatus and the distal end ofthe tubular member forms the distal most end of the apparatus; andwherein the base comprises a diameter that is at least three timesgreater than the cross-sectional width of the inner bore of the tubularmember.
 16. The apparatus according to claim 15, wherein the aperture ofthe base is configured to receive sterile retractors such that theretractors may be used to hold open the tubular member during insertionof the implant.
 17. The apparatus according to claim 15, wherein theaperture of the base is configured to receive the terminus of a conicalsleeve used to deliver the implant through the aperture of the base. 18.The apparatus according to claim 15, wherein the lower surface of thebase is operable to frictionally engage the skin of a subject, whereinthe frictional engagement resists movement of the base relative to theskin.
 19. The apparatus according to claim 18, wherein the lower surfacecomprises a surface operable to frictionally engage the skin of asubject once wetted.
 20. The apparatus according to claim 15, wherein anadhesive is disposed on the lower surface of the base.
 21. The apparatusaccording to claim 20, wherein the lower surface further comprises aremovable backing, the removable backing operable to expose theadhesive.
 22. The apparatus according to claim 15, wherein thepredetermined length is determined based on a distance between anincision in the skin of a patient and a surgically-created implantpocket formed below the skin.
 23. The apparatus according to claim 15,wherein the tubular member comprises an inner surface and an outersurface, the inner surface comprising a lubricant and defining the innerbore of tubular member.
 24. The apparatus according to claim 15, whereinthe predetermined length is greater than 1 cm.
 25. The apparatusaccording to claim 15, wherein the predetermined length is from about 2cm to about 10 cm.
 26. The apparatus according to claim 15, wherein thebase extends away from the tubular member in substantially the sameplane as the aperture of the base.
 27. The apparatus according to claim15, wherein the base comprises a diameter that is from about three (3)to five (5) times greater than the cross-sectional width of the innerbore of the tubular member.
 28. The apparatus according to claim 15,wherein the tubular member is stretchable.
 29. The apparatus accordingto claim 15, wherein the base and the tubular member are formed from aflexible material, the flexible material selected from the groupconsisting of plastic-containing fabrics, polymers, plastics,polyethylene terephthalate, vinyls, polyvinyl chloride, ethylene andalpha-olefin copolymers, silicone, solid silicone, silicone rubber, andany combination thereof.
 30. The apparatus according to claim 15,wherein the lower surface of the base is operable to removably engagethe skin of the subject so as to substantially resist movement of thebase relative to the skin of the subject during implant insertion intothe aperture and inner bore.